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Theory and Practice Compatibility of Pharmaceutical Products and Packaging
Author: |
China National Pharmaceutical |
Publisher: |
chemical industry press |
Publication Date: |
2019.10 |
Description
This book is a handbook of compatibility studies applied to the entire life cycle of pharmaceutical products. It is applied to emphasize the application of compatibility studies in the management of the entire life cycle of pharmaceuticals. It covers not only the drug product development phase, but also various phases and aspects such as process validation, routine quality control of drug package, drug package changes and post-marketing deviation OOS investigations.
The book is divided into two major parts: theory and practice:
--The latest definitions of pharmaceutical packaging and compatibility studies in 2019;
--Decision trees for pharmaceutical and packaging compatibility studies;
--Presents the concept and application of simulation studies;
--Templates for compatibility study reports are given;
--Analysis and discussion of real cases from companies;