Overview

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

Full Product Details

Author:   David J. Mazzo ,  David J. Mazzo
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 17.80cm , Height: 2.50cm , Length: 25.40cm
Weight:   0.810kg
ISBN:  

9781574910780

ISBN 10:   1574910787
Pages:   350
Publication Date:   31 August 1998
Audience:   Professional and scholarly ,  College/higher education ,  General/trade ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.

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David J. Mazzo

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