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...