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ICH Quality Guidelines: An Implementation Guide
Hardcover
Medical ReferenceTechnology & EngineeringChemistry
ISBN13: 9781118971116
Publisher: Wiley
Published: Oct 2 2017
Pages: 736
Weight: 2.45
Height: 1.60 Width: 6.30 Depth: 9.10
Language: English
- 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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