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| drug development and product 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 development and product management: Career Opportunities in Biotechnology and Drug Development Toby Freedman, 2008 An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere. |
| drug development and product management: Drug Discovery and Development - E-Book Raymond G Hill, 2012-07-20 The modern pharmacopeia has enormous power to alleviate disease, and owes its existence almost entirely to the work of the pharmaceutical industry. This book provides an introduction to the way the industry goes about the discovery and development of new drugs. The first part gives a brief historical account from its origins in the mediaeval apothecaries' trade, and discusses the changing understanding of what we mean by disease, and what therapy aims to achieve, as well as summarising case histories of the discovery and development of some important drugs. The second part focuses on the science and technology involved in the discovery process: the stages by which a promising new chemical entity is identified, from the starting point of a medical need and an idea for addressing it. A chapter on biopharmaceuticals, whose discovery and development tend to follow routes somewhat different from synthetic compounds, is included here, as well as accounts of patent issues that arise in the discovery phase, and a chapter on research management in this environment. The third section of the book deals with drug development: the work that has to be undertaken to turn the drug candidate that emerges from the discovery process into a product on the market. - The definitive introduction to how a pharmaceutical company goes about its business of discovering and developing drugs. The second edition has a new editor: Professor Raymond Hill ● non-executive director of Addex Pharmaceuticals, Covagen and of Orexo AB ● Visiting Industrial Professor of Pharmacology in the University of Bristol ● Visiting Professor in the School of Medical and Health Sciences at the University of Surrey ● Visiting Professor in Physiology and Pharmacology at the University of Strathclyde ● President and Chair of the Council of the British Pharmacological Society ● member of the Nuffield Council on Bioethics and the Advisory Council on Misuse of Drugs. New to this edition: - Completely rewritten chapter on The Role of Medicinal Chemistry in the Drug Discovery Process. - New topic - DMPK Optimization Strategy in drug discovery. - New chapter on Scaffolds: Small globular proteins as antibody substitutes. - Totally updated chapters on Intellectual Property and Marketing - 50 new illustrations in full colour Features - Accessible, general guide to pharmaceutical research and development. - Examines the interfaces between cost and social benefit, quality control and mass production, regulatory bodies, patent management, and all interdisciplinary intersections essential to effective drug development. - Written by a strong team of scientists with long experience in the pharmaceutical industry. - Solid overview of all the steps from lab bench to market in an easy-to-understand way which will be accessible to non-specialists. From customer reviews of the previous edition: '... it will have everything you need to know on this module. Deeply referenced and, thus, deeply reliable. - Highly Commended in the medicine category of the BMA 2006 medical book competition - Winner of the Royal Society of Medicine Library Prize for Medical Book of the Year |
| drug development and product 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 development and product 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 development and product management: Artificial Intelligence in Drug Discovery Nathan Brown, 2020-11-04 Following significant advances in deep learning and related areas interest in artificial intelligence (AI) has rapidly grown. In particular, the application of AI in drug discovery provides an opportunity to tackle challenges that previously have been difficult to solve, such as predicting properties, designing molecules and optimising synthetic routes. Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation. Providing a wealth of information from leading experts in the field this book is ideal for students, postgraduates and established researchers in both industry and academia. |
| drug development and product management: Early Drug Development Mitchell N. Cayen, 2011-02-25 The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies. |
| drug development and product 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 development and product management: Fundamentals of Drug Development Jeffrey S. Barrett, 2022-09-07 Fundamentals of DRUG DEVELOPMENT Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include: Drug development and its phases Decision-making processes, drug development milestones, and compound progression metrics The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development Differences in the nature and scope of development programs due to the therapeutic area of interest Associated costs and resources required Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process. |
| drug development and product 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 development and product management: Pharmaceutical and Biomedical Project Management in a Changing Global Environment Scott D. Babler, 2011-01-06 Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers. |
| drug development and product management: Drug Development Charles E. Hamner, 2019-06-12 Published in 1990: Overall the volume stands as a relatively comprehensive but not exhaustive summation of the complex process of drug development. |
| drug development and product 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 development and product 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 development and product management: Biological Drug Products Wei Wang, Manmohan Singh, 2013-08-29 Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases. |
| drug development and product management: Software Innovations in Clinical Drug Development and Safety Chakraborty, Partha, 2015-10-02 In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security. |
| drug development and product management: Bioinformatics Tools for Pharmaceutical Drug Product Development Vivek Chavda, K. Anand, Vasso Apostolopoulos, 2023-03-14 BIOINFORMATICS TOOLS FOR Pharmaceutical DRUG PRODUCT DLEVELOPMENT A timely book that details bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies, for drug development in the pharmaceutical and medical sciences industries. The book contains 17 chapters categorized into 3 sections. The first section presents the latest information on bioinformatics tools, artificial intelligence, machine learning, computational methods, protein interactions, peptide-based drug design, and omics technologies. The following 2 sections include bioinformatics tools for the pharmaceutical sector and the healthcare sector. Bioinformatics brings a new era in research to accelerate drug target and vaccine design development, improving validation approaches as well as facilitating and identifying side effects and predicting drug resistance. As such, this will aid in more successful drug candidates from discovery to clinical trials to the market, and most importantly make it a more cost-effective process overall. Readers will find in this book: Applications of bioinformatics tools for pharmaceutical drug product development like process development, pre-clinical development, clinical development, commercialization of the product, etc.; The ever-expanding application of this novel technology and discusses some of the unique challenges associated with such an approach; The broad and deep background, as well as updates, on recent advances in both medicine and AI/ML that enable the application of these cutting-edge bioinformatics tools. Audience The book will be used by researchers and scientists in academia and industry including drug developers, computational biochemists, bioinformaticians, immunologists, pharmaceutical and medical sciences, as well as those in artificial intelligence and machine learning. |
| drug development and product management: Marketing of High-technology Products and Innovations Jakki J. Mohr, Sanjit Sengupta, Stanley F. Slater, 2010 This title provides a thorugh overview of the issues high-tech marketers must address, and provides a balance between conceptual discussions and examples; small and big business; products and services; and consumer and business-to-business marketing contexts. |
| drug development and product 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 development and product management: The Future of Pharmaceutical Product Development and Research , 2020-08-19 The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. |
| drug development and product management: Managing Projects in Research and Development Ron Basu, 2016-03-09 Research and Development is the vehicle by which organizations and economies create opportunity, innovation and secure a stream of future products and services.These outcomes are all critically important sources of sustainability in a world that is changing faster than most companies can keep up.The challenge behind them is the fundamental unpredictability of R&D; which is why effective project management is so important. Ron Basu's Managing Projects in Research and Development explains how and why project management can provide a means of helping to plan, organise and control multi-disciplinary research activities without stifling innovation. Combining research with practical examples and experience from a career that has included blue chip organizations such as GSK, GlaxoWellcome and Unilever, Ron Basu offers a rigorous guide to the fundamentals of R&D project management including project lifecycle management, risk management, cost, time quality and other success measures as well as the keys to operational excellence in this complicated world. |
| drug development and product management: New Drug Development Mark P. Mathieu, 1987 |
| drug development and product management: The Right Price Peter J. Neumann, Joshua T. Cohen, Daniel A. Ollendorf, 2021 The prescription drug market -- Proposed solutions for rising drug prices -- Measuring the value of prescription drugs -- Measuring drug value : whose job is it anyway? -- Institute for Clinical and Economic Review (ICER) -- Other US value assessment frameworks -- Do drugs for special populations warrant higher prices? -- Improving value measurement -- Aligning prices with value -- The path forward. |
| drug development and product 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 development and product management: Managing the Drug Discovery Process Susan Miller, Walter Moos, Barbara Munk, Stephen Munk, Charles Hart, David Spellmeyer, 2023-03-09 Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing experienced perspectives on biomedical research, drug hunting and innovation, including the requisite educational paths that enable students to chart a career path in this field. The book also considers the interplay of stakeholders, consumers, and drug firms with respect to a myriad of factors. Since drug research can be a high-risk, high-payoff industry, it is important to students and researchers to understand how to effectively and strategically manage both their careers and the drug discovery process. This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharmaceutical industry. - Considers drug discovery in multiple R&D venues - big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes - with a clear description of the degrees and training that will prepare students well for a career in this arena - Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work - Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable - Addresses new areas such as CRISPR gene editing technologies and RNA-based drugs and vaccines, personalized medicine and ethical and moral issues, AI/machine learning and other in silico approaches, as well as completely updating all chapters |
| drug development and product management: Statistical Issues in Drug Development Stephen S. Senn, 2008-02-28 Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component. |
| drug development and product management: Special Topics in Drug Discovery Taosheng Chen, Sergio Chai, 2016-11-30 Drug discovery involves multiple disciplines, technologies, and approaches. This book selects important topics related to drug discovery, including emerging tool (Chapter 1), cutting-edge approaches (Chapters 2, 3, and 4), examples of specific therapeutic area (Chapter 5), quality control in drug development (Chapter 6), and job and career opportunities in the pharmaceutical sector, a topic rarely covered by other books (Chapter 7). This book draws knowledge from experts actively involved in different areas of drug discovery from both industrial and academic settings. We hope that this book will facilitate your efforts in drug discovery. |
| drug development and product management: Computational Drug Delivery Pooja A. Chawla, Dilpreet Singh, Kamal Dua, Muralikrishnan Dhanasekaran, Viney Chawla, 2024-10-07 The book bridges the gap between pharmaceutics and molecular modelling at the micro, meso and macro scale. It covers Lipinski's rule of five, nanoparticulate drug delivery, computational prediction of drug solubility and ability to cross blood brain barrier, computer-based simulation of pharmacokinetic parameters, virtual screening of mucoadhesive polymers, QSPR modelling, designing of 2D nanomaterials and role of principal component analysis. |
| drug development and product management: How to Develop Robust Solid Oral Dosage Forms Bhavishya Mittal, 2016-10-05 How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. - Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues |
| drug development and product management: Polymorphism in the Pharmaceutical Industry Rolf Hilfiker, Markus von Raumer, 2019-01-04 Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry. |
| drug development and product 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 development and product management: Lab-on-a-chip Devices for Advanced Biomedicines Arpana Parihar, Piyush Pradeep Mehta, 2024-08-14 The global miniature devices market is poised to surpass a valuation of $12–$15 billion USD by the year 2030. Lab-on-a-chip (LOC) devices are a vital component of this market. Comprising a network of microchannels, electrical circuits, sensors, and electrodes, LOC is a miniaturized integrated device platform used to streamline day-to-day laboratory functions, run cost-effective clinical analyses and curb the need for centralized instrumentation facilities in remote areas. Compact design, portability, ease of operation, low sample volume, short reaction time, and parallel investigation stand as the pivotal factors driving the widespread acceptance of LOC within the biomedical community. In this book, the Editors meticulously explore LOC through three key ‘Ts’: Theories (microfluidics, microarrays, instrumentation, software); Technologies (additive manufacturing, artificial intelligence, computational thinking, smart consumables, scale-up tactics, and biofouling); and Trends (biomedical analysis, point-of-care diagnostics, personalized healthcare, bioactive synthesis, disease diagnosis, and space applications) This comprehensive text not only provides readers with a thorough understanding of the current advancements in the LOC domain but also offers valuable insights to support the utilization of miniaturized devices for enhanced healthcare practices. Aimed at career researchers looking for instruction in the topic and newcomers to the area, the book is also useful for undergraduate and postgraduate students embarking on new studies or for those interested in reading about the LOC platform. |
| drug development and product management: Management Control Systems, Decision-Making, and Innovation Development Dawid Szutowski, 2021-10-03 The systematic approach to innovation development today is one of the world’s most prominent scientific fields, and with good reason. When applied correctly, such system produces regular outcomes, which consistently drive lasting competitive advantage. Unfortunately, as much as it is beneficial, the orchestration of an undisturbed flow of multiple complex, dynamic, and flexible innovation development processes is structurally demanding. In this book, a recognised innovation management specialist sets the record straight, offering a comprehensive approach to the improvement of innovation efficiency with the use of management control system. Unlike other books on the subject, it proposes original representation – the CDI model – of the relationships between management control system, decision-making quality, and innovation system efficiency and explains why management control is fundamental to innovation management. In addition to that, inside the reader will find several original developments. These include: the info-deficiency (I-D) model, depicting the various parameters hindering decision-making in innovation development; the product innovation development (PID) system, offering the original function-based approach to innovation management; and the composite innovation index – specially designed tool intended to evaluate the efficiency of an innovation development system. It will be of interest to researchers, academics, practitioners, and advanced students in the fields of management, strategy, and innovation. Chapter 4 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license available at http://www.taylorfrancis.com |
| drug development and product management: Handbook of Marketing Decision Models Berend Wierenga, 2008-09-05 Marketing models is a core component of the marketing discipline. The recent developments in marketing models have been incredibly fast with information technology (e.g., the Internet), online marketing (e-commerce) and customer relationship management (CRM) creating radical changes in the way companies interact with their customers. This has created completely new breeds of marketing models, but major progress has also taken place in existing types of marketing models. Handbook of Marketing Decision Models presents the state of the art in marketing decision models. The book deals with new modeling areas, such as customer relationship management, customer value and online marketing, as well as recent developments in other advertising, sales promotions, sales management, and competition are dealt with. New developments are in consumer decision models, models for return on marketing, marketing management support systems, and in special techniques such as time series and neural nets. |
| drug development and product 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 development and product management: Real-World Evidence in Drug Development and Evaluation Harry Yang, Binbing Yu, 2021-01-11 Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise |
| drug development and product management: Data Science, AI, and Machine Learning in Drug Development Harry Yang, 2022-10-04 The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data science stands at a unique moment of opportunity to lead such a transformative change. Intended to be a single source of information, Data Science, AI, and Machine Learning in Drug Research and Development covers a wide range of topics on the changing landscape of drug R & D, emerging applications of big data, AI and ML in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations. Features Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and ML in the entire spectrum of drug R & D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides a detailed description of solutions suitable for practitioners with limited data science expertise |
| drug development and product management: Nanomedicine Thomas J Webster, 2023-03-14 Nanomedicine: Technologies and Applications, Second Edition provides an important review of this exciting technology and its growing range of applications. In this new edition, all chapters are thoroughly updated and revised, with new content on antibacterial technologies and green nanomedicine. Sections introduce the material, cover their properties, review nanomedicine for therapeutics, imaging and soft tissue engineering, including organ regeneration, skin grafts, nanotubes and self-assembled nanomaterials. Other sections cover bone and cartilage tissue engineering, nanostructured particles for antibacterial purposes, advances in green nanomedicine, and using natural nanomedicine to fight disease. This book is an indispensable guide for all those involved in the research, development and application of this exciting technology, whilst also providing a comprehensive introduction for students and academics interested in this field. - Provides an important review of nanomedicine technology and its growing range of applications - Discusses key nanomedicine materials and their properties, including nanocrystalline metals, alloys and nanoporous gold and hydroxyapatite coatings - Features updated content in all parts, as well as a number of new chapters on antibacterial nanomedicine and green nanomedicine |
| drug development and product management: Computational Approaches in Drug Discovery, Development and Systems Pharmacology Rupesh Kumar Gautam, Mohammad Amjad Kamal, Pooja Mittal, 2023-02-15 Computational Approaches in Drug Discovery, Development and Systems Pharmacology provides detailed information on the use of computers in advancing pharmacology. Drug discovery and development is an expensive and time-consuming practice, and computer-assisted drug design (CADD) approaches are increasing in popularity in the pharmaceutical industry to accelerate the process. With the help of CADD, scientists can focus on the most capable compounds so that they can minimize the synthetic and biological testing pains. This book examines success stories of CADD in drug discovery, drug development and role of CADD in system pharmacology, additionally including a focus on the role of artificial intelligence (AI) and deep machine learning in pharmacology. Computational Approaches in Drug Discovery, Development and Systems Pharmacology will be useful to researchers and academics working in the area of CADD, pharmacology and Bioinformatics. - Explains computer use in pharmacology using real-life case studies - Provides information about biological activities using computer technology, thus allowing for the possible reduction of the number of animals used for research - Describes the role of AI in pharmacology and applications of CADD in various diseases |
| drug development and product management: Computational Drug Discovery Pooja A. Chawla, Dilpreet Singh, Kamal Dua, Muralikrishnan Dhanasekaran, Viney Chawla, 2024-10-07 Computational methods and understanding computational models are important in modern drug discovery. The book focuses on computational approaches that can improve the development of in silico methodologies. It includes lead hit methods, docking algorithms, computational chiral compounds, structure-based drug design, GROMACS and NAMD, structural genomics, toxicity prediction, enzyme inhibitors and peptidomimetic therapeutics |
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 …
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 …
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 …
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 …
