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Wiley ICH Quality Guidelines: An Implementation Guide
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Description
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)
Key Features
ICH Quality Guidelines: An Implementation Guide
Product type: ABIS_BOOK
Brand: Wiley
Product Specifications
- Brand
- Wiley
- Format
- hardcover
- ASIN
- 1118971116
- Domain
- Amazon UK
- Release Date
- 31 January 2017
- Listed Since
- 15 May 2014
Barcode
No barcode data available
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