Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.
This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.
The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com
