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CRC Press Generic Drug Product Development: Bioequivalence 180

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Description

Navigating the complexities of generic pharmaceutical development requires a deep understanding of bioequivalence. This textbook from CRC Press addresses the essential process of comparing the bioavailability of a generic drug product against its brand-name counterpart. Because generic products must be approved as therapeutic equivalents to be interchangeable, mastering bioequivalence is a fundamental part of the development cycle. Bioequivalence studies represent a significant investment in terms of time and capital, and they carry the risk of failure. This resource provides a detailed look at the specific bioequivalence issues that developers face during the assessment process. By focusing on the requirements for therapeutic equivalence, this book serves as a guide for professionals working within the pharmaceutical sciences to manage the challenges of drug development more effectively.

Key Features

Provides a detailed look at the assessment of bioequivalence to compare generic drug products with brand-name alternatives.

Explains the requirements for generic pharmaceutical products to be approved as therapeutic equivalents for interchangeability.

Addresses the specific challenges and issues encountered during bioequivalence studies to help manage development risks.

Offers professional insights into the high costs and time-consuming nature of conducting successful bioequivalence research.

Serves as a technical resource for those working in the pharmaceutical sciences and drug product development.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
15 February 2010
Listed Since
08 February 2007

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