(DOWNLOAD) "ICH Quality Guidelines" by Andrew Teasdale, David Elder & Raymond W. Nims " eBook PDF Kindle ePub Free
eBook details
- Title: ICH Quality Guidelines
- Author : Andrew Teasdale, David Elder & Raymond W. Nims
- Release Date : January 29, 2017
- Genre: Pharmacology & Toxicology,Books,Professional & Technical,Medical,
- Pages : * pages
- Size : 33480 KB
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)
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