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ICH Quality Guidelines
Language: en
Pages: 624
Authors: Andrew Teasdale
Categories: Medical
Type: BOOK - Published: 2017-09-29 - Publisher: John Wiley & Sons

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Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integra
International Conference on Harmonisation (ICH) Quality Guidelines
Language: en
Pages: 650
Authors: Mindy J. Allport-Settle
Categories: Medical
Type: BOOK - Published: 2010-05 - Publisher: Pharmalogika

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ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] *
Handbook of Stability Testing in Pharmaceutical Development
Language: en
Pages: 389
Authors: Kim Huynh-Ba
Categories: Medical
Type: BOOK - Published: 2008-11-16 - Publisher: Springer Science & Business Media

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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presen
Strategic Scientific and Medical Writing
Language: en
Pages: 147
Authors: Pieter H. Joubert
Categories: Medical
Type: BOOK - Published: 2015-11-27 - Publisher: Springer

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A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may
Development and Validation of Analytical Methods
Language: en
Pages: 363
Authors: Christopher M. Riley
Categories: Science
Type: BOOK - Published: 1996-05-29 - Publisher: Elsevier

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The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel