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Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 1439845689
Category : Medical
Languages : en
Pages : 199
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Book Description
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Su
Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 1439845689
Category : Medical
Languages : en
Pages : 199
Get Book Here
Book Description
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Su
Author: Michael K. Pugsley
Publisher: Springer
ISBN: 366246943X
Category : Medical
Languages : en
Pages : 477
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Book Description
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
Publisher: Academic Press
ISBN: 9780128122068
Category : Medical
Languages : en
Pages : 0
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Book Description
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: Fabrizio Giordanetto
Publisher: John Wiley & Sons
ISBN: 3527801774
Category : Science
Languages : en
Pages : 872
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Book Description
This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Author: H. Gerhard Vogel
Publisher: Springer
ISBN: 9783642252396
Category : Medical
Languages : en
Pages : 0
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Book Description
-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide
Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878160
Category : Medical
Languages : en
Pages : 903
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Book Description
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 0203499182
Category : Medical
Languages : en
Pages : 207
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Book Description
The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Con
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 1119097401
Category : Medical
Languages : en
Pages : 918
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Book Description
This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
Author: Terry P. Kenakin
Publisher: Academic Press
ISBN: 0128037539
Category : Medical
Languages : en
Pages : 340
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Book Description
Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action. The concepts discussed in this book allow for the application of more predictive pharmacological procedures aimed at increasing therapeutic efficacy that will lead to more successful drug development. Chapters logically build upon one another to show how to characterize the pharmacology of any given molecule and allow for more informed predictions of drug effects in all biological systems. New chapters are dedicated to the interdisciplinary drug discovery environment in both industry and academia, and special techniques involved in new drug screening and lead optimization. This edition has been fully revised to address the latest advances and research related to real time kinetic assays, pluridimensional efficacy, signaling bias, irreversible and chemical antagonism, allosterically-induced bias, pharmacokinetics and safety, target and pathway validation, and much more. With numerous valuable chapter summaries, detailed references, practical examples and case studies throughout, Dr. Kenakin successfully navigates a highly complex subject, making it accessible for students, professors, and new researchers working in pharmacology and drug discovery. - Includes example-based cases that illustrate how the pharmacological concepts discussed in this book lead to practical outcomes for further research - Provides vignettes on those researchers and scientists who have contributed significantly to the fields of pharmacology and drug discovery throughout history - Offers sample questions throughout the book and an appendix containing answers for self-testing and retention
Author: Andrew E. Mulberg
Publisher: John Wiley & Sons
ISBN: 1118312058
Category : Medical
Languages : en
Pages : 782
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Book Description
Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
