Catalent Pharma Solutions will host a free Webinar featuring Senior Manager, Wei Pan, Ph.D. RAC and Kathy Waddle, Director, Stability QC Biology. The one-hour Webinar will cover stability studies as a critical part of the drug development process and the vital role they play for drug product marketing approval. The Webinar, titled “Stability Studies in Pharmaceutical Development,” will be held on Friday, November 20, 2009 at 2 p.m. (EST). To register for the Webinar please visit: https://www2.gotomeeting.com/register/280747146.
The presentation will address the principles and practices of stability studies in the drug development process. Pan and Waddle will discuss the framework of the FDA cGMP guidelines as expressed in 21CFR211. Additionally, the Webinar will provide a comprehensive review of ICH and WHO stability guidelines by discussing the strategy used in stability protocols designed to support global registration.
Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.
For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.