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Image of - Safety Pharmacology in Pharmaceutical Development | 2nd Edition | Hardcover
Safety Pharmacology in Pharmaceutical Development | 2nd Edition | Hardcover

Safety Pharmacology in Pharmaceutical Development | 2nd Edition | Hardcover

by Gad

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 Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the authors more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

Highlights

  • binding-icon

    9781439845677

    ISBN:

  • binding-icon

    Gad

    Author:

  • binding-icon

    213

    Pages:

  • binding-icon

    215 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2012

    Year:

  • edition-icon

    2nd Edition

    Edition:

  • binding-icon

    Hardcover

    Binding:

₹16936

₹21170

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 Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the authors more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.

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