| Ich Quality Guidelines: An Implementation Guide Contributor(s): Teasdale, Andrew (Editor), Elder, David (Editor), Nims, Raymond W. (Editor) |
|
 |
ISBN: 1118971116 ISBN-13: 9781118971116 Publisher: Wiley OUR PRICE: $356.20 Product Type: Hardcover - Other Formats Published: October 2017 |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Technology & Engineering | Quality Control - Science | Chemistry - Industrial & Technical |
| Dewey: 615.19 |
| LCCN: 2017013162 |
| Physical Information: 1.6" H x 6.3" W x 9.1" (2.45 lbs) 736 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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) |
