Ich Quality Guidelines: An Implementation Guide

By Raymond W Nims and David Elder

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)

• Format: Hardcover
• Language: English
• ISBN: 1118971116
• ISBN13: 9781118971116
• Release Date: October 2017
• Publisher: Wiley
• Length: 736 Pages
• Weight: 2.45 lbs.
• Dimensions: 1.6" x 6.3" x 9.1"