Safety Pharmacology in Pharmaceutical Development

Approval and Post Marketing Surveillance, Second Edition

AvShayne C. Gad

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Engelska, 2012

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Beskrivning

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. This volume covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author's more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.

Produktinformation

Utgivningsdatum:2012-04-26
Språk:Engelska
Filformat:EPUB
Kopieringsskydd:LCP
ISBN:9781040162545
Förlag:Taylor & Francis Ltd
Upplaga:2

Utforska kategorier

Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik

Mer om författaren

Shayne Cox Gad is Principal at Gad Consulting Services in Cary, North Carolina. He has over 33 years experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries.

Innehållsförteckning

Safety Pharmacology: Background, History, Issues, and Concerns. Regulatory Requirements: ICH, FDA, EMA, and Japan. Principles of Screening and Study Design. Cardiovascular System. Central Nervous System. Respiratory System. Renal Function. The Gastrointestinal System. The Immune System.