Safety Evaluation Of Biotechnologically Derived Pharmaceuticals

Author : Susan A. Griffiths,C. Lumley
Publisher : Springer Science & Business Media
Page : 208 pages
File Size : 50,8 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9789401148764

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Safety Evaluation of Biotechnologically-derived Pharmaceuticals by Susan A. Griffiths,C. Lumley Pdf

Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.

Author : Anonim
Publisher : Unknown
Page : 11 pages
File Size : 52,6 Mb
Release : 1997
Category : Biopharmaceutics
ISBN : OCLC:422767412

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Guidance for industry by Anonim Pdf

Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Page : 1012 pages
File Size : 49,6 Mb
Release : 2013-03-07
Category : Medical
ISBN : 9781118679388

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Preclinical Safety Evaluation of Biopharmaceuticals by Joy A. Cavagnaro Pdf

"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.

Author : Anonim
Publisher : Unknown
Page : 14 pages
File Size : 53,7 Mb
Release : 2009
Category : Drugs
ISBN : OCLC:493493259

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Addendum to ICH S6 by Anonim Pdf

Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
Publisher : John Wiley & Sons
Page : 492 pages
File Size : 45,8 Mb
Release : 2013-03-05
Category : Medical
ISBN : 9781118516980

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Nonclinical Safety Assessment by William J. Brock,Kenneth L. Hastings,Kathy M. McGown Pdf

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

Author : John A. Thomas
Publisher : CRC Press
Page : 296 pages
File Size : 47,8 Mb
Release : 1993-06-30
Category : Medical
ISBN : 0781700809

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Biotechnology And Safety Assessment by John A. Thomas Pdf

In this volume, experts from academe, industry, and public health institutes discuss the issues involved in toxicology evaluation, safety assessment, and regulation of biotechnology-derived drugs, foods, and plant products. Coverage includes recombinant DNA agents, monoclonal antibodies, recombinant hormones and other proteins, biotechnology-derived drug delivery systems, gene therapy for genetic diseases, and genetically engineered plants and plant products. Full consideration is given to key methodological issues in product development and testing, such as use of "in vitro" and "in vivo" toxicology tests, choice of animal models, and use of transgenic animal models and genetically altered species to study human diseases. The book includes an appendix describing available animal models and a glossary of terms, definitions, and acronyms.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1020 pages
File Size : 41,6 Mb
Release : 2003-09-05
Category : Medical
ISBN : 9780471459293

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Drug Safety Evaluation by Shayne Cox Gad Pdf

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

Author : Shayne Cox Gad,Dexter W. Sullivan, Jr.
Publisher : John Wiley & Sons
Page : 996 pages
File Size : 46,7 Mb
Release : 2023-01-12
Category : Medical
ISBN : 9781119755852

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Drug Safety Evaluation by Shayne Cox Gad,Dexter W. Sullivan, Jr. Pdf

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Author : Shayne C. Gad
Publisher : Springer
Page : 126 pages
File Size : 40,5 Mb
Release : 2010-10-27
Category : Medical
ISBN : 1441974482

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Safety Evaluation of Pharmaceuticals and Medical Devices by Shayne C. Gad Pdf

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

Author : Oliver Kayser,Heribert Warzecha
Publisher : John Wiley & Sons
Page : 677 pages
File Size : 51,5 Mb
Release : 2012-05-21
Category : Science
ISBN : 9783527329946

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Pharmaceutical Biotechnology by Oliver Kayser,Heribert Warzecha Pdf

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

Author : John Talbot,Jeffrey K. Aronson
Publisher : John Wiley & Sons
Page : 751 pages
File Size : 41,6 Mb
Release : 2011-12-19
Category : Medical
ISBN : 9780470986349

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Stephens' Detection and Evaluation of Adverse Drug Reactions by John Talbot,Jeffrey K. Aronson Pdf

Written with practitioners in mind, this new edition of Stephen’s Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Author : National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Board on Life Sciences,Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health
Publisher : National Academies Press
Page : 254 pages
File Size : 48,7 Mb
Release : 2004-07-08
Category : Science
ISBN : 9780309166157

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Safety of Genetically Engineered Foods by National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Board on Life Sciences,Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health Pdf

Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them. The book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.

Author : Gary Walsh
Publisher : John Wiley & Sons
Page : 499 pages
File Size : 52,8 Mb
Release : 2013-04-25
Category : Science
ISBN : 9781118685754

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Pharmaceutical Biotechnology by Gary Walsh Pdf

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific ‘product category chapters’ focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Author : John A. Thomas,Roy L. Fuchs
Publisher : Elsevier
Page : 400 pages
File Size : 42,7 Mb
Release : 2002-09-05
Category : Science
ISBN : 008052818X

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Biotechnology and Safety Assessment by John A. Thomas,Roy L. Fuchs Pdf

A comprehensive treatise on new developments in biotechnology, the authors of Biotechnology and Safety Assessment, 3e, bring readers an up-to-date review of food safety issues, pre-clinical safety and development of new foods and drugs, plant biotechnology, food allergies and safety assessment, and consumer benefits with regard to genetically modified food. Tomorrow's foods will be obtained from genetically modified crops, offering consumers higher nutritional value and more of it. Our medications will be obtained through a variety of biotechnological procedures yielding more potent and specific medications for diseases and vaccines. In order to make this view of the future come to light, John A. Thomas and Roy L. Fuchs have updated their classic in order to keep readers one step ahead. Written by internationally recognized molecular biologists, plant agronomists, microbiologists, toxicologists, nutritionists, and regulatory authorities, this third edition is an excellent and authoritative resource, making it a valuable resource to any biomedical library or scientific bookshelf. Provides timely coverage on topics of agribiotechnology and biotherapeutics Describes the recent progress in genetically modified crops and their safety Presents an update of the newer developments in therapeutic agents Discusses role of genetically modified microorganisms in the development of new food products Outlines various global regulatory issues relating to GM crops Addresses environmental and ecological topics related to GM crops

Author : Danuta J. Herzyk,Jeanine L. Bussiere
Publisher : John Wiley & Sons
Page : 433 pages
File Size : 48,9 Mb
Release : 2008-11-21
Category : Medical
ISBN : 9780470386378

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Immunotoxicology Strategies for Pharmaceutical Safety Assessment by Danuta J. Herzyk,Jeanine L. Bussiere Pdf

An important reference which provides an overview of the current and recently introduced methodologies for testing the immunotoxic risks in drug candidates Helps readers understand the significance of the methods and approaches to immunotoxicology testing Aids drug scientists in industry and regulatory areas to consolidate approaches to immunotox testing Offers a definitive assessment of nonclinical models to study the toxic impacts (bio)pharmaceuticals can have on the immune system Includes chapter authors from across the pharma industry, bringing a real-world and applied perspective to immunotox testing