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Anglický jazyk
ICH Quality Guidelines
Autor: Andrew Teasdale
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. *... Viac o knihe
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353.12 €
bežná cena: 371.70 €
O knihe
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)
- Vydavateľstvo: John Wiley & Sons
- Rok vydania: 2017
- Formát: Hardback
- Rozmer: 235 x 157 mm
- Jazyk: Anglický jazyk
- ISBN: 9781118971116
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