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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.
Safety pharmacology investigates the unintended pharmacological effects of potential drugs that could pose a hazard, especially to vulnerable populations. This volume details the regulatory requirements for safety pharmacology studies and the scientific justification behind them. Drawing on over 30 years of experience, the author provides practical insights into conducting these studies effectively and understanding the reasons for their failure.
The book is structured to provide practical guidance for professionals in pharmaceutical development, leveraging the author's extensive experience. Its focus on both regulatory mandates and the practicalities of study execution suggests it serves as a valuable resource for researchers and developers navigating the complexities of drug safety assessment. The inclusion of 'tricks and practical insights' indicates an aim to offer actionable advice beyond theoretical principles.
Page Count:
1152
Publication Date:
2012-04-26
Publisher:
Taylor & Francis
ISBN-10:
1040162541
ISBN-13:
9781040162545
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