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ICH Quality Guidelines: An Implementation Guide (in English)
Raymond W. Nims
(Illustrated by)
·
Andrew Teasdale
(Illustrated by)
·
David Elder
(Illustrated by)
·
Wiley
· Hardcover
ICH Quality Guidelines: An Implementation Guide (in English) - Teasdale, Andrew ; Elder, David ; Nims, Raymond W.
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Synopsis "ICH Quality Guidelines: An Implementation Guide (in English)"
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)
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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Hardcover.
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