ICH Quality Guidelines. An Implementation Guide. David Elder

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Название: ICH Quality Guidelines. An Implementation Guide

Автор: David Elder

Издательство: John Wiley & Sons Limited

Жанр: Медицина

Серия:

isbn: 9781118971123

isbn: 0

Аннотация:

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)