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)
| ISBN: | 9781118971116 |
| Publication date: | 15th December 2017 |
| Author: | Andrew Teasdale |
| Publisher: | John Wiley & Sons Inc |
| Format: | Hardback |
| Pagination: | 736 pages |
| Genres: |
Industrial chemistry and chemical engineering Chemistry |