The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.
This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.
Regulatory and Scientific Considerations for API Drug Development is being presented by Dr. William Putnam, Director, Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. (a Cardinal Health company) and airs on Wednesday, August 26, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
