ICH Quality Guidelines: An Implementation Guide
By: and and
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- Synopsis
- 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)
- Copyright:
- 2018
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9781118971130
- Related ISBNs:
- 9781118971147, 9781118971116
- Publisher:
- Wiley
- Date of Addition:
- 09/30/17
- Copyrighted By:
- Wiley
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Technology, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.
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