ICH Quality Guidelines

An Implementation Guide

By: Andrew Teasdale, David Elder, Raymond W. Nims

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eText | 29 September 2017 | Edition Number 1

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Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.

•   Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
•   Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
•   Uses case studies to help readers understand and apply ICH guidelines
•   Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
•   Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)