Advertisement
| dose optimization fda guidance: Pharmacometrics Ene I. Ette, Paul J. Williams, 2013-03-14 Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies. |
| dose optimization fda guidance: Bayesian Adaptive Methods for Clinical Trials Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Peter Muller, 2010-07-19 Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti |
| dose optimization fda guidance: Guideline on General Principles of Process Validation , 1987 |
| dose optimization fda guidance: The Drug Development Paradigm in Oncology National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, National Cancer Policy Forum, 2018-02-12 Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop. |
| dose optimization fda guidance: Preclinical Safety Evaluation of Biopharmaceuticals Joy A. Cavagnaro, 2013-03-07 The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies. —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel. |
| dose optimization fda guidance: Drug Discovery and Evaluation: Methods in Clinical Pharmacology H.Gerhard Vogel, Jochen Maas, Alexander Gebauer, 2010-12-15 Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series Drug Discovery and Evaluation in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series Pharmacological Assays comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays. Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology. |
| dose optimization fda guidance: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| dose optimization fda guidance: 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. |
| dose optimization fda guidance: Pharmacokinetic-Pharmacodynamic Modeling and Simulation Peter L. Bonate, 2011-07-01 This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated. |
| dose optimization fda guidance: Guideline for Submitting Samples and Analytical Data for Methods Validation , 1987 |
| dose optimization fda guidance: Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection World Health Organization, 2016 These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly. |
| dose optimization fda guidance: Dosage Form Design Considerations , 2018-07-28 Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design |
| dose optimization fda guidance: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent must-know guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals. |
| dose optimization fda guidance: Flow Cytometry Alice Longobardi Givan, 2013-04-10 Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature. |
| dose optimization fda guidance: Phase I Cancer Clinical Trials Elizabeth A. Eisenhauer, Chris Twelves, Marc E. Buyse, 2014-06 Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. As this title is the only comprehensive book on this topic, it is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials. |
| dose optimization fda guidance: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Agency for Health Care Research and Quality (U.S.), 2013-02-21 This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov) |
| dose optimization fda guidance: Dermatological Drug Development Tomoko Maeda-Chubachi, Elizabeth Kernodle Hussey, Sylvia Furst, 2020-09-18 This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan). |
| dose optimization fda guidance: Medical Devices and the Public's Health Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2011-11-25 Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. |
| dose optimization fda guidance: Cancer Crossings Tim Wendel, 2018-04-15 When Eric Wendel was diagnosed with acute lymphoblastic leukemia in 1966, the survival rate was 10 percent. Today, it is 90 percent. Even as politicians call for a Cancer Moonshot, this accomplishment remains a pinnacle in cancer research. The author’s daughter, then a medical student at Georgetown Medical School, told her father about this amazing success story. Tim Wendel soon discovered that many of the doctors at the forefront of this effort cared for his brother at Roswell Park in Buffalo, New York. Wendel went in search of this extraordinary group, interviewing Lucius Sinks, James Holland, Donald Pinkel, and others in the field. If there were a Mount Rushmore for cancer research, they would be on it. Despite being ostracized by their medical peers, these doctors developed modern-day chemotherapy practices and invented the blood centrifuge machine, helping thousands of children live longer lives. Part family memoir and part medical narrative, Cancer Crossings explores how the Wendel family found the courage to move ahead with their lives. They learned to sail on Lake Ontario, cruising across miles of open water together, even as the campaign against cancer changed their lives forever. |
| dose optimization fda guidance: 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 |
| dose optimization fda guidance: Toxicokinetics , 1995 |
| dose optimization fda guidance: Addressing the Barriers to Pediatric Drug Development Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2008-08-12 Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children. |
| dose optimization fda guidance: Approved Drug Products with Therapeutic Evaluations DIANE Publishing Company, 1995-09 Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons. |
| dose optimization fda guidance: Pharmaceutical Process Validation Bernard T. Loftus, Robert A. Nash, 1984 |
| dose optimization fda guidance: Extractables and Leachables Dennis Jenke, 2022-08-02 EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing. |
| dose optimization fda guidance: Chirality in Drug Design and Development Indra K. Reddy, Reza Mehvar, 2004-03-15 Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characteristics of specific enantiomers and chiral drug compounds and addresses in one convenient reference all the major challenges pertaining to drug chirality that have been neglected in the literature. Chirality in Drug Design and Development collects the latest studies from an interdisciplinary team of experts on chiral drug design. |
| dose optimization fda guidance: Applied Pharmacokinetics William E. Evans, Jerome J. Schentag, William J. Jusko, 1992 The Third Edition of Applied Pharmacokinetics remains the gold standard by which all other clinical pharmacokinetics texts are measured. Written by leading pharmacokinetics researchers and practitioners, this book is the most advanced kinetics reference available. All chapters have been extensively updated or completely rewritten for this edition, and six new chapters have been added on pharmacodynamics, pharmacogenetics, pharmacokinetic considerations in the obese, dietary influences on drug disposition, zidovudine, and corticosteroids. Each chapter is tightly focused on the most important concepts and issues. Chapters on specific drugs are organized in a consistent format for quick, easy information retrieval. Major subheadings include Clinical Pharmacokinetics, Pharmacodynamics, Clinical Application of Pharmacokinetic Data, Analytical Methods, and Prospectus. |
| dose optimization fda guidance: Introduction to Linear Regression Analysis Douglas C. Montgomery, Elizabeth A. Peck, G. Geoffrey Vining, 2015-06-29 Praise for the Fourth Edition As with previous editions, the authors have produced a leading textbook on regression. —Journal of the American Statistical Association A comprehensive and up-to-date introduction to the fundamentals of regression analysis Introduction to Linear Regression Analysis, Fifth Edition continues to present both the conventional and less common uses of linear regression in today’s cutting-edge scientific research. The authors blend both theory and application to equip readers with an understanding of the basic principles needed to apply regression model-building techniques in various fields of study, including engineering, management, and the health sciences. Following a general introduction to regression modeling, including typical applications, a host of technical tools are outlined such as basic inference procedures, introductory aspects of model adequacy checking, and polynomial regression models and their variations. The book then discusses how transformations and weighted least squares can be used to resolve problems of model inadequacy and also how to deal with influential observations. The Fifth Edition features numerous newly added topics, including: A chapter on regression analysis of time series data that presents the Durbin-Watson test and other techniques for detecting autocorrelation as well as parameter estimation in time series regression models Regression models with random effects in addition to a discussion on subsampling and the importance of the mixed model Tests on individual regression coefficients and subsets of coefficients Examples of current uses of simple linear regression models and the use of multiple regression models for understanding patient satisfaction data. In addition to Minitab, SAS, and S-PLUS, the authors have incorporated JMP and the freely available R software to illustrate the discussed techniques and procedures in this new edition. Numerous exercises have been added throughout, allowing readers to test their understanding of the material. Introduction to Linear Regression Analysis, Fifth Edition is an excellent book for statistics and engineering courses on regression at the upper-undergraduate and graduate levels. The book also serves as a valuable, robust resource for professionals in the fields of engineering, life and biological sciences, and the social sciences. |
| dose optimization fda guidance: Clinical Data Management Richard K. Rondel, Sheila A. Varley, Colin F. Webb, 2000-02-03 Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research. |
| dose optimization fda guidance: Development of Biopharmaceutical Drug-Device Products Feroz Jameel, John W. Skoug, Robert R. Nesbitt, 2020-03-13 The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field. |
| dose optimization fda guidance: 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 |
| dose optimization fda guidance: In Vitro-In Vivo Correlations David B. Young, John G. Devane, Jackie Butler, 2013-03-08 This book represents the invited presentations and some of the posters presented at the conference entitled In Vitro-In Vivo Relationship (IVIVR) Workshop held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development. |
| dose optimization fda guidance: Public Health Service Policy on Humane Care and Use of Laboratory Animals National Institutes of Health (U.S.). Office for Protection from Research Risks, 1986 |
| dose optimization fda guidance: Volunteers in Research and Testing Bryony Close, R. Coomber, Anthony Hubbard, John Illingworth, 1997-02-01 This text discusses the use of volunteers, either healthy or undergoing treatment, in the research and testing of medicinal and non-medicinal products. The extent to which the improved use of such volunteers could reduce the need for animal tests is |
| dose optimization fda guidance: Rethinking Cancer Bernhard Strauss, Marta Bertolaso, Ingemar Ernberg, Mina J. Bissell, 2021-04-27 Leading scientists argue for a new paradigm for cancer research, proposing a complex systems view of cancer supported by empirical evidence. Current consensus in cancer research explains cancer as a disease caused by specific mutations in certain genes. After dramatic advances in genome sequencing, never before have we known so much about the individual cancer cell--and yet never before has it been so unclear what to do with this knowledge. In this volume, leading researchers argue for a new theory framework for understanding and treating cancer. The contributors propose a complex systems view of cancer, presenting conceptual building blocks for a new research paradigm supported by empirical evidence. The contributors first discuss the new research framework in terms of theoretical foundations and then take up the relevance of a systems approach, reviewing such topics as nonlinearity, recurrence after treatment, the cellular attractor concept, network theory, and non-coding DNA--the dark matter of our genome. They address the temporality of cancer progression, drawing on evolutionary theory and clinical experience. Finally, they cover the dominant role of the tissue microenvironment in cancer, analyzing topics including altered metabolic pathways, the disease-defining influence on metastasis, and the interconnectedness of different environmental niches across levels of organization. |
| dose optimization fda guidance: The Management of Breastfeeding Rebecca F. Black, Leasa Jarman, Jan Simpson, 1998 The Management of Breastfeeding covers the developmental stages of infancy, including sensory capabilities and reflexes, nutritional needs of the mother-infant dyad, And The assessment and management of infant and mother health issues related to breastfeeding. The exams at the end of Modules 1, 2, 3, and 4, while still useful in preparing For The IBCLC exam, are not eligible for CERPS or Continuing Education credits for registered dietitians or nurses. The Lactation Specialist Self Study Series is comprised of four modules: Module 1: The Support of Breastfeeding (0-7637-0208-0) Module 2: The Process of Breastfeeding (0-7637-0195-5) Module 3: The Science of Breastfeeding (0-7637-0194-7) Module 4: The Management of Breastfeeding (0-7637-0193-9) the modules may be purchased separately, or as a complete set (0-7637-1974-9). |
| dose optimization fda guidance: Recognition and Alleviation of Pain in Laboratory Animals National Research Council, Division on Earth and Life Studies, Institute for Laboratory Animal Research, Committee on Recognition and Alleviation of Pain in Laboratory Animals, 2010-01-14 The use of animals in research adheres to scientific and ethical principles that promote humane care and practice. Scientific advances in our understanding of animal physiology and behavior often require theories to be revised and standards of practice to be updated to improve laboratory animal welfare. Recognition and Alleviation of Pain in Laboratory Animals, the second of two reports revising the 1992 publication Recognition and Alleviation of Pain and Distress in Laboratory Animals from the Institute for Laboratory Animal Research (ILAR), focuses on pain experienced by animals used in research. This book aims to educate laboratory animal veterinarians; students, researchers and investigators; Institutional Animal Care and Use Committee members; and animal care staff and animal welfare officers on the current scientific and ethical issues associated with pain in laboratory animals. It evaluates pertinent scientific literature to generate practical and pragmatic guidelines for recognizing and alleviating pain in laboratory animals, focusing specifically on the following areas: physiology of pain in commonly used laboratory species; pharmacologic and non-pharmacologic principles to control pain; identification of humane endpoints; and principles for minimizing pain associated with experimental procedures. Finally, the report identifies areas in which further scientific investigation is needed to improve laboratory animal welfare. |
| dose optimization fda guidance: 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 |
| dose optimization fda guidance: Dose Finding and Beyond in Biopharmaceutical Development Jingjing Ye, |
| dose optimization fda guidance: Handbook of Bioequivalence Testing Sarfaraz K. Niazi, 2007-08-22 As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more difficult to conduct and summarize. The Handbook of Bioequivalence Testing offers a complete description of every aspect of bioequivalence testing. Features: Describes the current analytical methods used in bioequivalence testing, as well as their respective strengths and limitations Discusses worldwide regulatory requirements for filing for approval of generic drugs Covers GLP, GCP, and 21 CFR compliance requirements for qualifying studies for regulatory submission and facility certification Includes actual examples of reports approved by regulatory authorities to illustrate various scientific, regulatory, and formatting aspects Provides a list of vendors for the software used to analyze bioequivalence studies and recommendations Explains how to apply for a waiver, how to secure regulatory approval of reports, and how to obtain regulatory certification of facilities conducting bioequivalence studies |
Dose - Wellness Shots
Explore Dose's range of all-natural, organic wellness shots, designed to support liver, skin, muscle soreness, and immune health.
DOSE Definition & Meaning - Merriam-Webster
The meaning of DOSE is the measured quantity of a therapeutic agent to be taken at one time. How to use dose in a sentence.
DOSE | English meaning - Cambridge Dictionary
DOSE definition: 1. a measured amount of something such as medicine: 2. an amount or experience of something, often…. Learn more.
Difference Between Drug Dose and Dosage - Verywell Health
Oct 4, 2023 · A drug dose is a specific amount or weight of medication. A dosage attaches time to a dose. Learn different examples of taking a dose of a prescription.
Dose - definition of dose by The Free Dictionary
Define dose. dose synonyms, dose pronunciation, dose translation, English dictionary definition of dose. n. 1. a. A specified quantity of a therapeutic agent, such as medicine, prescribed to be …
DOSE definition and meaning | Collins English Dictionary
A dose of medicine or a drug is a measured amount of it which is intended to be taken at one time. One dose of penicillin can wipe out the infection. Try to take your daily dose of the medicine at …
dose - Wiktionary, the free dictionary
May 18, 2025 · dose (third-person singular simple present doses, present participle dosing, simple past and past participle dosed) (transitive) To administer a dose (of medicine) to. "She thought …
Dose (biochemistry) - Wikipedia
A dose is a measured quantity of a medicine, nutrient, or pathogen that is delivered as a unit. The greater the quantity delivered, the larger the dose. Doses are most commonly measured for …
DOSE Definition & Meaning | Dictionary.com
Dose definition: a quantity of medicine prescribed to be taken at one time.. See examples of DOSE used in a sentence.
Dose Definition & Meaning | Britannica Dictionary
DOSE meaning: 1 : the amount of a medicine, drug, or vitamin that is taken at one time; 2 : an amount of a substance
Dose - Wellness Shots
Explore Dose's range of all-natural, organic wellness shots, designed to support liver, skin, muscle soreness, and immune health.
DOSE Definition & Meaning - Merriam-Webster
The meaning of DOSE is the measured quantity of a therapeutic agent to be taken at one time. How to use dose in a sentence.
DOSE | English meaning - Cambridge Dictionary
DOSE definition: 1. a measured amount of something such as medicine: 2. an amount or experience of something, often…. Learn more.
Difference Between Drug Dose and Dosage - Verywell Health
Oct 4, 2023 · A drug dose is a specific amount or weight of medication. A dosage attaches time to a dose. Learn different examples of taking a dose of a prescription.
Dose - definition of dose by The Free Dictionary
Define dose. dose synonyms, dose pronunciation, dose translation, English dictionary definition of dose. n. 1. a. A specified quantity of a therapeutic agent, such as medicine, prescribed to be …
DOSE definition and meaning | Collins English Dictionary
A dose of medicine or a drug is a measured amount of it which is intended to be taken at one time. One dose of penicillin can wipe out the infection. Try to take your daily dose of the …
dose - Wiktionary, the free dictionary
May 18, 2025 · dose (third-person singular simple present doses, present participle dosing, simple past and past participle dosed) (transitive) To administer a dose (of medicine) to. "She thought …
Dose (biochemistry) - Wikipedia
A dose is a measured quantity of a medicine, nutrient, or pathogen that is delivered as a unit. The greater the quantity delivered, the larger the dose. Doses are most commonly measured for …
DOSE Definition & Meaning | Dictionary.com
Dose definition: a quantity of medicine prescribed to be taken at one time.. See examples of DOSE used in a sentence.
Dose Definition & Meaning | Britannica Dictionary
DOSE meaning: 1 : the amount of a medicine, drug, or vitamin that is taken at one time; 2 : an amount of a substance
