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CRC Press Generic Drug Product Development: Bioequivalence Issues - CRC Press

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1 day · current 3 days 10 days 34 days 10 days 10 days 6 days 0 9 17 26 34 £18 £27 £28 £41 £42 £45 £185 Days at Price

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Description
This comprehensive textbook examines the critical process of assessing bioequivalence in generic pharmaceutical products, exploring how generic drugs must demonstrate therapeutic equivalence to their brand-name counterparts before market approval. Bioequivalence studies represent a substantial investment of time and resources, with inherent risks of failure, making this detailed exploration essential for pharmaceutical professionals. The book addresses specific bioequivalence issues that practitioners must consider when developing and evaluating generic drug products, providing practical insights into the regulatory framework and scientific methodology governing generic drug approval. Designed for allied health professionals and pharmacy practitioners, this volume (180 in the Drugs and the Pharmaceutical Sciences series) serves as a technical reference for understanding the complex relationship between generic and branded pharmaceuticals, the demonstration of therapeutic equivalence, and the interchangeability requirements that guide modern pharmaceutical development and clinical practice.

Key Features

CRC Press publication covering bioequivalence assessment methods essential for generic drug product development and regulatory approval.

Explores the comparison of bioavailability between generic drugs and brand-name counterparts to establish therapeutic equivalence.

Addresses specific bioequivalence issues relevant to pharmaceutical scientists and healthcare practitioners in allied health professions.

Part of the established Drugs and the Pharmaceutical Sciences series (Volume 180), providing authoritative guidance on pharmaceutical science.

Comprehensive resource for understanding the costly and time-intensive bioequivalence study process and its potential challenges.

Product Specifications
Brand
CRC Press
Format
hardcover
ASIN
0849377846
Category
Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain
Amazon UK
Release Date
15 February 2010
Listed Since
08 February 2007

Barcode

No barcode data available

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