Advertisement
| drug life cycle management: Pharmaceutical Lifecycle Management Tony Ellery, Neal Hansen, 2012-06-05 A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation. |
| drug life cycle management: Pharmaceutical Lifecycle Management Tony Ellery, Neal Hansen, 2012-04-16 A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation. |
| drug life cycle management: Designing Sustainable Technologies, Products and Policies Enrico Benetto, Kilian Gericke, Mélanie Guiton, 2018-07-03 This open access book provides insight into the implementation of Life Cycle approaches along the entire business value chain, supporting environmental, social and economic sustainability related to the development of industrial technologies, products, services and policies; and the development and management of smart agricultural systems, smart mobility systems, urban infrastructures and energy for the built environment. The book is based on papers presented at the 8th International Life Cycle Management Conference that took place from September 3-6, 2017 in Luxembourg, and which was organized by the Luxembourg Institute of Science and Technology (LIST) and the University of Luxembourg in the framework of the LCM Conference Series. |
| drug life cycle management: Global Supply Chains in the Pharmaceutical Industry Nozari, Hamed, Szmelter, Agnieszka, 2018-11-09 In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy. |
| drug life cycle management: The Generic Challenge Martin A. Voet, 2020-05-01 This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject. |
| drug life cycle management: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| drug life cycle management: The Life-Cycle of Pharmaceuticals in the Environment B.M. Peake, R. Braund, Alfred Tong, Louis A Tremblay, 2015-11-13 The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship. - Encompasses the full lifecycle of common pharmaceuticals, from prescription and dispensing practices to their occurrence in a range of different types of natural waters and their environmental impact - Explores the role of the healthcare system and its affect on users - Beneficial for environmental engineers involved in the design and operation of appropriate degradation technologies of the pharmaceutical prescription and disposal practices |
| drug life cycle management: Generic Drug Development Project Management Sandeep Narayan Patil, PMP, 2021-04-17 This is the first book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book includes generic drug development project in detail. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf. |
| drug life cycle management: Pharmaceutical Medicine and Translational Clinical Research Divya Vohora, Gursharan Singh, 2017-11-14 Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery |
| drug life cycle management: Improving and Accelerating Therapeutic Development for Nervous System Disorders Institute of Medicine, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2014-02-06 Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials. |
| drug life cycle management: The Textbook of Pharmaceutical Medicine John P. Griffin, John O'Grady, 2008-04-15 New edition of succesful standard reference book for thepharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebookfor the Diploma in Pharmaceutical Medicine, and is used as astandard reference throughout the pharmaceutical industry. The newedition includes greater coverage of good clinical practice, acompletely revised statistics chapter, and more on safety. Coversthe course information for the Diploma in PharmaceuticalMedicine Fully updated, with new authors Greater coverage of good clinical practice and safety New chapters on regulation of medical devices in Europe andregulation of therapeutic products in Australia |
| drug life cycle management: Innovation and Marketing in the Pharmaceutical Industry Min Ding, Jehoshua Eliashberg, Stefan Stremersch, 2013-10-31 The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike. |
| drug life cycle management: Pharmaceutical Drug Product Development and Process Optimization Sarwar Beg, Majed Al Robaian, Mahfoozur Rahman, Syed Sarim Imam, Nabil Alruwaili, Sunil Kumar Panda, 2020-05-01 Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. |
| drug life cycle management: Pharmaceutical Product Development Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee, 2016-05-25 Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive |
| drug life cycle management: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| drug life cycle management: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| drug life cycle management: Development and Validation of Analytical Methods Christopher M. Riley, Thomas W. Rosanske, 1996-05-29 The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation. |
| drug life cycle management: Pain Management and the Opioid Epidemic National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, 2017-09-28 Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring. |
| drug life cycle management: Drug Repurposing and Repositioning Institute of Medicine, Board on Health Sciences Policy, Roundtable on Translating Genomic-Based Research for Health, 2014-08-08 Drug development can be time-consuming and expensive. Recent estimates suggest that, on average, it takes 10 years and at least $1 billion to bring a drug to market. Given the time and expense of developing drugs de novo, pharmaceutical companies have become increasingly interested in finding new uses for existing drugs - a process referred to as drug repurposing or repositioning. Historically, drug repurposing has been largely an unintentional, serendipitous process that took place when a drug was found to have an offtarget effect or a previously unrecognized on-target effect that could be used for identifying a new indication. Perhaps the most recognizable example of such a successful repositioning effort is sildenafil. Originally developed as an anti-hypertensive, sildenafil, marketed as Viagra and under other trade names, has been repurposed for the treatment of erectile dysfunction and pulmonary arterial hypertension. Viagra generated more than $2 billion worldwide in 2012 and has recently been studied for the treatment of heart failure. Given the widespread interest in drug repurposing, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine hosted a workshop on June 24, 2013, in Washington, DC, to assess the current landscape of drug repurposing activities in industry, academia, and government. Stakeholders, including government officials, pharmaceutical company representatives, academic researchers, regulators, funders, and patients, were invited to present their perspectives and to participate in workshop discussions. Drug Repurposing and Repositioning is the summary of that workshop. This report examines enabling tools and technology for drug repurposing; evaluates the business models and economic incentives for pursuing a repurposing approach; and discusses how genomic and genetic research could be positioned to better enable a drug repurposing paradigm. |
| drug life cycle management: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| drug life cycle management: Product Lifecycle Management (Volume 1) John Stark, 2015-04-10 This third edition updates and adds to the successful second edition and gives the reader a thorough description of PLM, providing them with a full understanding of the theory and the practical skills to implement PLM within their own business environment. This new and expanded edition is fully updated to reflect the many technological and management advances made in PLM since the release of the second edition. Describing the environment in which products are developed, manufactured and supported, before addressing the Five Pillars of PLM: business processes, product data, PLM applications, Organisational Change Management (OCM) and Project Management, this book explains what Product Lifecycle Management is, and why it’s needed. The final part of the book addresses the PLM timeline, showing the typical steps and activities of a PLM project or initiative. “Product Lifecycle Management” will broaden the reader’s understanding of PLM, nurturing the skills needed to implement PLM successfully and to achieve world-class product performance across the lifecycle. |
| drug life cycle management: Project Management for the Pharmaceutical Industry Laura Brown, Tony Grundy, 2016-04-08 The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management. |
| drug life cycle management: Product Lifecycle Management John Stark, 2011-08-12 Product Lifecycle Management (2nd edition) explains what Product Lifecycle Management (PLM) is, and why it's needed. It describes the environment in which products are developed, realised and supported, before looking at the basic components of PLM, such as the product, processes, applications, and people. The final part addresses the implementation of PLM, showing the steps of a project or initiative, and typical activities. This new and expanded edition of Product Lifecycle Management is fully updated to reflect the many advances made in PLM since the release of the first edition. It includes descriptions of PLM technologies and examples of implementation projects in industry. Product Lifecycle Management will broaden the reader’s understanding of PLM, nurturing the skills needed to implement PLM successfully and to achieve world-class product performance across the lifecycle. “A 20-year veteran of PLM, I highly recommend this book. A clear and complete overview of PLM from definition to implementation. Everything is there - reasons, resources, strategy, implementation and PLM project management.” Achim Heilmann, Manager, Global Technical Publications, Varian Medical Systems “Product Lifecycle Management is an important technology for European industry. This state-of-the art book is a reference for those implementing and researching PLM.” Dr. Erastos Filos, Head of Sector Intelligent Manufacturing Systems, European Commission “This book, written by one of the best experts in this field, is an ideal complement for PLM courses at Bachelor and Master level, as well as a well-founded reference book for practitioners.” Prof. Dr.-Ing. Dr. h.c. Sandor Vajna, University of Magdeburg, Germany “This comprehensive book can help drive an understanding of PLM at all levels – from CEOs to CIOs, and from professors to students – that will help this important industry continue to expand and thrive.” James Heppelmann, President and Chief Executive Officer, PTC “PLM is a mission-critical decision-making system leveraged by the world’s most innovative companies to transform their process of innovation on a continuous basis. That is a powerful value proposition in a world where the challenge is to get better products to the market faster than ever before. That is the power of PLM.” Tony Affuso, Chairman and CEO, Siemens PLM Software |
| drug life cycle management: The Price of Global Health Ed Schoonveld, 2011 The Price of Global Health is the first book of its kind: an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much needed and invaluable resource for anybody interested, involved in or affected by the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs. |
| drug life cycle management: Therapeutic Risk Management of Medicines Stephen J. Mayall, Anjan Swapu Banerjee, 2014-04-16 Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders.A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US.This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. - An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines - A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) - A comprehensive guide for performing risk management more effectively throughout a product's life-cycle |
| drug life cycle management: Pharmacy Management Shane P. Desselle, David P. Zgarrick, 2005 Editors Desselle and Zgarrick have brought together 33 contributed chapters in their endeavor to prepare pharmacy students for the realities of managing a practice. After a section on why it's important to study management in pharmacy school, coverage includes the various ins-and-outs of managing oneself (understanding stress), operations, people, |
| drug life cycle management: The Changing Economics of Medical Technology Institute of Medicine, Committee on Technological Innovation in Medicine, 1991-02-01 Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€as well as the involvement of numerous government agenciesâ€affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public. |
| drug life cycle management: Versed Rae Armantrout, 2010-08 A collection of poetry organized in two sections. The first section, Versed, play with vice and versa, the perversity of human consciousness. They flirt with error and delusion, skating on a thin ice that inevitably cracks. The second section, Dark Matter, alludes to more than the unseen substance thought to make up the majority of mass in the universe. The invisible and unknowable are confronted directly as the author's experience with cancer marks these poems with a new austerity, shot through with her signature wit and stark unsentimental thinking.--Résumé de l'éditeur. |
| drug life cycle management: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on Ensuring Patient Access to Affordable Drug Therapies, 2018-03-01 Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€and health care at largeâ€more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€coupled with the broader trends in overall health care costsâ€is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care. |
| drug life cycle management: Quality by Design for Biopharmaceutical Drug Product Development Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe, 2015-04-01 This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs. |
| drug life cycle management: Challenges for the FDA Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2007-10-02 As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement. |
| drug life cycle management: New Drugs Lawrence Tim Friedhoff, 2009 Drug development, the processes by which a chemical compound becomes a drug and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products. |
| drug life cycle management: Drug Discovery and Development, Third Edition James J. O'Donnell, John Somberg, Vincent Idemyor, James T. O'Donnell, 2019-12-13 Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business |
| drug life cycle management: Oral Controlled Release Formulation Design and Drug Delivery Hong Wen, Kinam Park, 2011-01-14 This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues. |
| drug life cycle management: Generic Drug Product Development Leon Shargel, Isadore Kanfer, 2013-10-24 In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral |
| drug life cycle management: Ask a Manager Alison Green, 2018-05-01 From the creator of the popular website Ask a Manager and New York’s work-advice columnist comes a witty, practical guide to 200 difficult professional conversations—featuring all-new advice! There’s a reason Alison Green has been called “the Dear Abby of the work world.” Ten years as a workplace-advice columnist have taught her that people avoid awkward conversations in the office because they simply don’t know what to say. Thankfully, Green does—and in this incredibly helpful book, she tackles the tough discussions you may need to have during your career. You’ll learn what to say when • coworkers push their work on you—then take credit for it • you accidentally trash-talk someone in an email then hit “reply all” • you’re being micromanaged—or not being managed at all • you catch a colleague in a lie • your boss seems unhappy with your work • your cubemate’s loud speakerphone is making you homicidal • you got drunk at the holiday party Praise for Ask a Manager “A must-read for anyone who works . . . [Alison Green’s] advice boils down to the idea that you should be professional (even when others are not) and that communicating in a straightforward manner with candor and kindness will get you far, no matter where you work.”—Booklist (starred review) “The author’s friendly, warm, no-nonsense writing is a pleasure to read, and her advice can be widely applied to relationships in all areas of readers’ lives. Ideal for anyone new to the job market or new to management, or anyone hoping to improve their work experience.”—Library Journal (starred review) “I am a huge fan of Alison Green’s Ask a Manager column. This book is even better. It teaches us how to deal with many of the most vexing big and little problems in our workplaces—and to do so with grace, confidence, and a sense of humor.”—Robert Sutton, Stanford professor and author of The No Asshole Rule and The Asshole Survival Guide “Ask a Manager is the ultimate playbook for navigating the traditional workforce in a diplomatic but firm way.”—Erin Lowry, author of Broke Millennial: Stop Scraping By and Get Your Financial Life Together |
| drug life cycle management: Pharmaceutical Quality by Design Sarwar Beg, Md Saquib Hasnain, 2019-03-27 Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies |
| drug life cycle management: The Drug Discovery and Development Cycle Kabir Hussain, 2020-07-19 The pharmaceutical drug discovery and development cycle is long and complex. This book provides a concise overview of the whole process and offers insights into working in the pharmaceutical industry. It is ideal for individuals who are thinking about a career in this industry, as well as those who want to gain a general understanding of pharmaceutical drug discovery and development. |
| drug life cycle management: Guideline on General Principles of Process Validation , 1987 |
| drug life cycle management: Pharmaceutical Medicine Adrian Kilcoyne, Phil Ambery, Daniel O'Connor, 2013-05-23 The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career. |
Drugs.com - Prescription Drug Information
Drugs.com is the most popular, comprehensive and up-to-date source of drug information online. Providing free, peer-reviewed, accurate and independent data on more than 24,000 …
Drug - Wikipedia
A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. [1] Consumption of drugs …
WebMD Drugs & Medications - Medical information on …
Answer your medical questions on prescription drugs, vitamins and Over the Counter medications. Find medical information, terminology and advice including side effects, drug …
Drug | Definition, Types, Interactions, Abuse, & Facts | Britannica
May 31, 2025 · A drug is any chemical substance that affects the functioning of living things and the organisms (such as bacteria, fungi, and viruses) that infect them.
Drugs, Herbs and Supplements - MedlinePlus
Learn about your prescription drugs and over-the-counter medicines. Includes side effects, dosage, special precautions, and more. For FDA approved labels included in drug packages, …
Overview of Drugs - Drugs - MSD Manual Consumer Version
A drug is defined by U.S. law as any substance (other than a food or device) intended for use in the diagnosis, cure, relief, treatment, or prevention of disease or intended to affect the structure …
Drugs A to Z | National Institute on Drug Abuse (NIDA)
Apr 10, 2025 · Drugs A to Z gives basic information on drugs with addictive potential, including how they are used, how they make people feel, and their health effects, including risk for …
Drugs and Medications A-Z - Healthline
Learn about cost, uses, and more for Januvia (sitagliptin). It's a prescription drug that…
Drugs and Supplements - Mayo Clinic
Look up information about prescription drugs, over-the-counter medications, herbs, vitamins and supplements.
Substance Use Philly
Learn how to get harm reduction supplies or treatment, get overdose and drug supply data, and more. The Substance Use Prevention and Harm Reduction program provides information …
Pharmaceutical Product Life Cycle Management Strategies in …
Pharmaceutical Product Life Cycle Management Strategies in the Contemporary scenario Dr. Ayush Kumar 1 , Dr. Somanchi Hari Krishna 2 , S. Chandrasekhar 3 , Dr. M. Vssavi 4 , Dr. Ch. …
Lifecycle Management of Analytical Procedures: Method …
The lifecycle management process provides a framework for defining the criteria for and development of an analytical procedure that meets the acceptance criteria. The procedure …
Process Validation: Lifecycle Management - PQRI
for finished drug products: –21 CFR 211.100(a) [Foundation for PV] •“written procedures for production and process control designed to assure that the drug products have the identity, …
The Art of Manuscript Writing - lifesciences.enago.com
messaging the target audience. There are different types of scientific manuscripts developed to communicate data during the drug development phases as well as later in the life-cycle …
Digitally Enhanced Life Cycle Management for a Blockbuster …
Life Cycle Management (LCM) of a drug starts soon after the discovery of a lead compound and impacts development, approval, and commercialization through the loss of exclusivity and, …
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …
Food and Drug Administration [Docket No. FDA-2024-D-4488] Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission …
NEW DRUG COMMERCIALIZATION - Integrated Project …
when the drug is being developed in partnership between two companies. Using project management to plan and lead the activities of cross-functional teams is a core competency for …
Global CMC Dossier Life Cycle Management
Life Cycle Management PROGRAM CHAIRPERSON PAULA S. HUDSON Manager, CM&C Regulatory Affairs Eli Lilly and Company CHARLES P. IRELAND Associate Director, …
Overview: Pharmacovigilance and Risk Management - Journal …
Drug development is an expensive, lengthy, and high-risk ... extends throughout its full life cycle. As a result, there is added ... RMP = Risk Management Plan. *The phase(s) of the drug …
Contract Drug Manufacturers (CMOs): Keys to Success and …
with generic drug companies in the development of generic formulations or with branded drug makers in the development of life-cycle management programs for existing drugs. These …
Reformulation-Focused Life Cycle Management of the FDA …
Life cycle management (LCM) of a drug is the process of managing drug life cycle through fully realizing the commercial and clinical value, right from the initial developmental stages to the …
Use of Real‐World Data and Evidence in Drug Development …
11 categories divided over 5 stages of the drug development lifecycle. Nearly all EPARs included RWE signatures for the discovery (98.2%) and life-cycle management (100.0%). Half of them …
Considerations for the Use of Artificial Intelligence To Support ...
Center for Biologics Evaluation and Research . Food and Drug Administration . 10903 New Hampshire Ave., Bldg. 71, Room 3128 . Silver Spring, MD 20993-0002
Q12 - ICH
management of manufacturing changes across the supply chain is an essential part of an effective change management system. This guideline provides recommendations for robust …
Pharmaceutical Life Cycle Management (book)
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
A Review on Drug Combination Strategy for Pharma Life …
4 J Biol Today's World 2020; 9(3): 215. a drug, we have chosen the case study of sitagliptin phosphate where the FDCs improved its life cycle. Sitagliptin case study-an FDC product …
The Effective Management of Change Across the ICHQ10 …
Features of an Effective Change Control System 1 the guide • SOP that describes each of the key steps of: Evaluation of a change Approval to proceed with the change Implementation of the …
Q14 Analytical Procedure Development - U.S. Food and Drug …
Food and Drug Administration . Center for Drug Evaluation and Research (CDER) ... enhanced approach might be used to support development and life cycle management of analytical …
WHITEPAPER DIFFERING CMC REQUIREMENTS: US AND EU
Specialties: Global CMC requirements, life-cycle management, systems, procedures and workflows. 3 Introduction Over the course of the past years, companies’ economic interests …
PERSPECTIVES - Nature
Apr 7, 2006 · extending revenue generated by a drug (life-cycle management), development of a defence strategy against generic competi-tors, expansion and growth of an OTC drug
Drug Product Life-Cycle Management as Anticompetitive …
Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine Vincent C. Capati, PharmD, MS, and Aaron S. Kesselheim, MD, JD, MPH SUMMARY A …
Pharmaceutical Life Cycle Management (Download Only)
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
Regulatory Considerations of Bioassay Lifecycle Management …
Lifecycle Management For Biologics Bioassays, April 16, 2024 Leiyun Boone, PhD Lead Biologist, Office of Product Quality Assessment III (OPQA III) US Food and Drug Administration. …
Establishing a regulatory roadmap for post-approval lifecycle …
Product life cycle stage: Post-approval With the acquisition of a drug product from another pharmaceutical company, the client faced challenges with maintaining the track of post …
Pharmaceutical Life Cycle Management (2024)
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
FDA Post-Marketing Drug Safety Surveillance
Mar 7, 2017 · Management (DRISK) 9 . 10 Divisions of Pharmacovigilance . 10 Evaluate . Analyze . Action . Communicate ... of a Drug Product’s Life Cycle • Less frequent adverse …
Rising Health Care Costs and Life-Cycle Management in the ...
the drug price quickly falls. In this week’s PLOS Medicine, Nathalie Vernaz and colleagues study the consequences of this delicate balancing act going awry due to the cumulative effects of so …
Continuous Manufacturing - ISPE
drug substances and drug products, resulting in an increased likelihood of implementation across the globe. 24 AGILE, DATA˜DRIVEN LIFE CYCLE MANAGEMENT ... o˛ ers insights into life …
Drug Product Life-Cycle Management as Anticompetitive …
Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine Vincent C. Capati, PharmD, MS, and Aaron S. Kesselheim, MD, JD, MPH SUMMARY A …
Risk Management the Total Product Life Cycle (TPLC)
24 Sources: • 21 CFR 820, Quality System Regulations • ISO 13485:2016, Medical devices –quality management systems • ISO 14971:2019, Medical devices –Application of risk …
Pharmaceutical Life Cycle Management
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
Lifecycle CMC Management: ICH Q12 Progress to date
lead to disruption in supply chain and drug shortage Lifecycle Management workshop EMA 28-29 October 2015 6 . ICH Q12: Scope and Objectives • “….to facilitate the management of post …
Overview of Drug Development - ICH
drug is intended to treat life-threatening or severely-debilitating ... Life cycle management Clinical Development strategies Management of clinical programs Management of clinical programs …
Pharmaceutical Life Cycle Management - DRINK APPS MANGA
Pharmaceutical Life Cycle Management Nozari, Hamed,Szmelter, Agnieszka Pharmaceutical Lifecycle Management Tony Ellery,Neal Hansen,2012-06-05 A comprehensive guide to …
Drug Data Management Standard - Rx-360
Drug Data Management Standard (Exposure Draft) Translation graciously provided by the China Working Group of Rx-360 Chapter I General Provisions ... and regulations during the drug life …
RISK MANAGEMENT STRATEGIES IN PHARMACOVIGILANCE
Throughout the course of a drug's life cycle, the RMP is updated and changed on a regular basis. The FDA has put in place regulatory actions that fall under the category of risk management …
Lifecycle Management of Approved Drug Products- FDA …
FDA, USP, WHO, Lifecycle Management, Drug Development, Risk Based Evaluation, Pharmaceutical Quality, CMC Review Process, Drug Development Process Created Date …
Quality by Design for Biotechnology Products: An FDA …
Risk Management (Q9) and Pharmaceutical Quality System (Q10) as they pertain to the development and manufacture of drug substance. 2012: ICH Q11 Development and …
Pharmaceutical Life Cycle Management Copy
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
Pharmaceutical Life Cycle Management Full PDF
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
ICH Q12: Post Approval Change Management Protocol …
Apr 2, 2019 · 4. Post-Approval Change Management Protocol (PACMP) 5. Product Lifecycle Management (PLCM) 6. Pharmaceutical Quality System (PQS) and Change Management 7. …
Drug Development Course: From Molecule to Prescription
Drug Development Pathway: how to go from molecule to medicine target product profile types of compounds (small molecules - biologics - antibody / drug conjugates, vaccines) different …
Case Study 1: Risk Assessment and Lifecycle Management …
• The link between risk assessment and drug substance / drug product specification should be clear. The absence of potential CQA in the specification should be justified. • It should be …
Artificial Intelligence/Machine Learning-Driven Small Molecule ...
diligence; drug life cycle management 1. Introduction ... The drug repurposing computational framework involves a hierarchical approach, as shown in Figure1. The first step is two …
FROM THE ANALYST’S COUCH Drug life-cycle technologies
Life-cycle management of on-patent phar- ... which are made possible by drug life-cycle technologies. One of these technologies is chiral switching,which is described in Israel
Pharmaceutical Life Cycle Management Full PDF
indispensable reading for pharmaceutical executives and managers as well as anyone working in the fields of drug research development and regulation Pharmaceutical Lifecycle Management …
DRUG DEVELOPMENT: STAGES OF DRUG DISCOVERY AND …
phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market.[1,2] ... multifaceted project management. It also …
Risk Reviewed - cewh.ca
race/ethnicity related factors, along with social determinants and life course considerations, ... While Canada has made many strides in improving the integration of sex and gender into …
chapter 22 Managing distribution - Management Sciences …
23 Inventory management 24 Importation and port clearing 25 Transport management 26 Kit system management Use Summary 22.2 22.1 Figure 22-1Goals of distribution management …
Reflection paper on the use of Artificial Intelligence (AI) in the ...
Advice on risk management will be further reflected in future regulatory guidance, since the impact of system malfunction or suboptimal model performance can range from minimal to critical or …
