Preclinical Safety Evaluation Of Biopharmaceuticals

Author : Joy A. Cavagnaro,Mary Ellen Cosenza
Publisher : CRC Press
Page : 542 pages
File Size : 52,9 Mb
Release : 2021-11-26
Category : Medical
ISBN : 9781000471823

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Translational Medicine by Joy A. Cavagnaro,Mary Ellen Cosenza Pdf

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.

Author : Joy A. Cavagnaro
Publisher : John Wiley & Sons
Page : 1012 pages
File Size : 40,5 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 : Susan A. Griffiths,C. Lumley
Publisher : Springer Science & Business Media
Page : 208 pages
File Size : 50,7 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 : Joy Cavagnaro Phd,Mary Ellen Cosenza
Publisher : CRC Press
Page : 128 pages
File Size : 44,5 Mb
Release : 2017-04-15
Category : Electronic
ISBN : 1498766935

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Translational Medicine - Optimizing Preclinical Safety Evaluation of Biopharmaceuticals by Joy Cavagnaro Phd,Mary Ellen Cosenza Pdf

This book aims to provide scientists involved in the translation of novel biopharmaceuticals into clinical trials a better understanding of how best to navigate the valley of death. The goal is to define best practices for efficient leveraging of discovery research to facilitate a science-based, rational, efficient and predictive preclinical development program to ensure clinical efficacy and safety."

Author : H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
Publisher : Springer Science & Business Media
Page : 576 pages
File Size : 52,6 Mb
Release : 2010-12-15
Category : Medical
ISBN : 9783540898900

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology by H.Gerhard Vogel,Jochen Maas,Alexander Gebauer Pdf

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".

Author : John P. Griffin,John O'Grady
Publisher : John Wiley & Sons
Page : 883 pages
File Size : 41,7 Mb
Release : 2008-04-15
Category : Medical
ISBN : 9780470987261

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The Textbook of Pharmaceutical Medicine by John P. Griffin,John O'Grady Pdf

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

Author : Qi Jiang,H. Amy Xia
Publisher : CRC Press
Page : 382 pages
File Size : 49,6 Mb
Release : 2020-06-30
Category : Electronic
ISBN : 0367576007

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Quantitative Evaluation of Safety in Drug Development by Qi Jiang,H. Amy Xia Pdf

Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Features, Focuses on the quantitative evaluation of safety of biopharmaceutical products, Covers several Bayesian approaches, including a meta-experimental design for evaluating cardiovascular risk, adaptive trials for drug safety, and network meta-analysis for safety evaluation, Explains why a DMC safety report differs from a safety report written at the end of the trial, Describes the safety surveillance and signal detection process, Discusses the observational medical outcomes partnership (OMOP), Addresses regulatory issues in the meta-analysis of safety data, Presents safety evaluation and quantitative approaches during preclinical and early phases of drug development, Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area. Book jacket.

Author : Jan Willem van der Laan,Joseph J DeGeorge
Publisher : Springer Science & Business Media
Page : 322 pages
File Size : 51,7 Mb
Release : 2013-02-11
Category : Medical
ISBN : 9781461459507

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Global Approach in Safety Testing by Jan Willem van der Laan,Joseph J DeGeorge Pdf

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1020 pages
File Size : 48,6 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 : Michael K. Pugsley,Michael J Curtis
Publisher : Springer
Page : 481 pages
File Size : 55,7 Mb
Release : 2015-06-19
Category : Medical
ISBN : 9783662469439

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Principles of Safety Pharmacology by Michael K. Pugsley,Michael J Curtis Pdf

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Page : 0 pages
File Size : 47,9 Mb
Release : 2018-09-07
Category : Medical
ISBN : 0128122064

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Advanced Issue Resolution in Safety Pharmacology by Mary Jeanne Kallman,Michael Pugsley Pdf

Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

Author : Chi-Jen Lee,Lucia H. Lee,Christopher L. Wu,Benjamin R. Lee,Mei-Ling Chen
Publisher : CRC Press
Page : 520 pages
File Size : 41,7 Mb
Release : 2005-09-19
Category : Medical
ISBN : 9781420039146

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Clinical Trials of Drugs and Biopharmaceuticals by Chi-Jen Lee,Lucia H. Lee,Christopher L. Wu,Benjamin R. Lee,Mei-Ling Chen Pdf

The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an

Author : Lisa Plitnick,Danuta J. Herzyk
Publisher : Academic Press
Page : 0 pages
File Size : 41,6 Mb
Release : 2013-07-19
Category : Medical
ISBN : 012394810X

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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics by Lisa Plitnick,Danuta J. Herzyk Pdf

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 41,5 Mb
Release : 2009-06-17
Category : Science
ISBN : 9780470466353

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Clinical Trials Handbook by Shayne Cox Gad Pdf

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Author : Anonim
Publisher : Unknown
Page : 24 pages
File Size : 46,7 Mb
Release : 1995
Category : Drugs
ISBN : MINN:31951D013437920

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Toxicokinetics by Anonim Pdf