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CRC Press Generic Drug Product Development - Regulatory Guide

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£59.47 £56.50 £57.69 £58.88 £60.06 £61.25 £62.44 28 July 2026 02 August 2026 08 August 2026 14 August 2026 20 August 2026
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Description

As the global demand for lower cost drug therapy grows, the use of generic and multi-source drug products continues to increase. This professional text from CRC Press addresses the complex landscape of international patent and trade agreements. It provides essential information on how the development and sale of these products must conform to national and international laws. To ensure safety, generic products must prove they are of the same quality and are therapeutically equivalent to brand name alternatives. This title discusses the worldwide legislative and regulatory requirements necessary to navigate these standards, especially in regions where resources for inspecting and verifying drug product quality may be limited.

Key Features

This CRC Press publication covers international regulatory requirements for bioequivalence in drug development.

The text provides information on conforming to national and international laws for the sale of generic products.

It addresses the necessity of proving therapeutic equivalence between generic products and brand name alternatives.

The content explores the legislative requirements for drug products within the Drugs and the Pharmaceutical Sciences series.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
27 September 2019
Listed Since
02 January 2007

Barcode

No barcode data available

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