EAN: | 9781118971116 |
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Sachgruppe: | Chemie |
Sprache: | Englisch |
Seitenzahl: | 736 |
Produktart: | Gebunden |
Herausgeber: | Elder, David Nims, Raymond W Teasdale, Andrew |
Veröffentlichungsdatum: | 09.10.2017 |
Untertitel: | An Implementation Guide |
Schlagworte: | Medical / Nursing |
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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)