ICH Quality Guidelines: An Implementation Guide

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. ò Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies ò Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines ò Uses case studies to help readers understand and apply ICH guidelines ò Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines ò Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

• | Author: Andrew Teasdale, David Elder, Raymond W. Nims
• | Publisher: Wiley
• | Publication Date: Oct 09, 2017
• | Number of Pages: 736 pages
• | Language: English
• | Binding: Hardcover/Medical
• | ISBN-10: 1118971116
• | ISBN-13: 9781118971116