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. • 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)
ASIN: 1118971116
VSKU: LFV.1118971116.VG
Condition: Very Good
Author/Artist:Elder, David|Nims, Raymond W.|Teasdale, Andrew
Binding: Hardcover
Note: Any images shown are stock photographs and product may differ from what is shown.
Condition Notes: Book is in very good condition. Clean with little to no signs of wear or markings highlights.