scope:

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)

Authors: Andrew Teasdale, David Elder, Raymond W. Nims