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Author: Shayne C. Gad
Publisher: CRC Press
ISBN: 1439845689
Category : Medical
Languages : en
Pages : 213
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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 : 213
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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: 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: 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: 0128123346
Category : Medical
Languages : en
Pages : 362
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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. Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs
Author: H. Gerhard Vogel
Publisher: Springer Science & Business Media
ISBN: 3540256385
Category : Medical
Languages : en
Pages : 896
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Book Description
This book is a landmark in the continuously changing world of drugs. It is essential reading for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.
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: 0123878152
Category : Business & Economics
Languages : en
Pages : 904
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Book Description
A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0471459291
Category : Medical
Languages : en
Pages : 1020
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Book Description
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: Atlas Holmes
Publisher: American Medical Publishers
ISBN:
Category : Medical
Languages : en
Pages : 0
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Book Description
Safety pharmacology deals with the detection and analysis of the potential adverse pharmacodynamic and pharmacological effects of new chemical entities (NCEs) on physiological processes, apart from the desired therapeutic effects. Such adverse effects of NCEs can be dangerous, especially in people who have damaged or reduced organ system functions. Safety pharmacology is vital throughout the process of drug discovery and development. There are three main goals of non-clinical safety pharmacology evaluations. First goal is to protect phase I clinical trial volunteers from acute drug side effects; second goal is to protect patients (including patients in phase II and III clinical trials), and last goal is to reduce the risk of failure during drug development and post-marketing phase due to undesirable pharmacodynamic effects. It is a fast-growing area of study in pharmacology and requires regulatory guidance. This book is a valuable compilation of topics, ranging from the basic to the most complex advancements in safety pharmacology. It explores all the important aspects of this field in the present day scenario. This book will serve as a valuable reference source for students and researchers.
Author: Yaser Mohammed Al-Worafi
Publisher: Academic Press
ISBN: 0128204125
Category : Business & Economics
Languages : en
Pages : 656
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Book Description
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
