ICH quality guidelines : an implementation guide / edited by Andrew Teasdale, AstraZeneca, London, UK, David Elder, Consultant (former GSK), Hertford, Hertfordshire, UK, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA.
Material type: TextPublication details: John Wiley and Sons Inc.Edition: First editionDescription: xi, 721 pages : illustrations ; 24 cmISBN:- 9781118971116 (hardback)
- 1118971116 (hardback)
- International Conference on Harmonization quality guidelines
- 615.19 23
- RM301.25 .I24 2018
- MED071000 | TEC032000 | SCI013060
Item type | Current library | Home library | Collection | Call number | Status | Date due | Barcode |
---|---|---|---|---|---|---|---|
ACP-Regular Books | Acharya & BM Reddy College of Pharmacy | Acharya & BM Reddy College of Pharmacy | Quality As | 615.19 (Browse shelf(Opens below)) | Not for loan | ACP-R13031 |
Includes bibliographical references and index.
"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)"--
There are no comments on this title.