QbD perspectives and nanoparticle characterization
- In: R1 - IPS Workshop on PAT (Part 2) on Saturday, 30 August 2008, 9:00-17:00
- At: Basel (Switzerland) (2008)
- Type: Presentation
- By: KHAN, Mansoor (FDA, Silver Springs, Maryland, United States of America)
Abstract A rational design for the quality of a product with multivariate product and process understanding may alleviate some of the difficulties that are currently encountered due to product variability and failures. The availability of documents such as ICH Q8 and Q9 provide opportunities for regulatory flexibility with enhanced.. The access to the whole abstract and if available the presentation file is available to FIP members and to congress participants of that specific congress.