Active Pharmaceutical Ingredient (API) and Drug Product Specifications
Monday, July 19, 2010 - Wednesday, July 21, 2010
The Dolce Valley Forge
King of Prussia, United States
http://www.cfpie.com/showitem.aspx?productid=011&source=inpharmfree
Event Type: Training Course
This continually updated course covers the entire gamut of operations in the development of a New Chemical Entity (NCE) - from discovery to the filing of a New Drug Application. Emphasis will be placed on discussing stability issues, impurity profiles, polymorphism, bioequivalence, bioavailability and chemical route selection. Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection. Participants will also understand the specifications needed to meet current FDA regulatory requirements and ICH guidelines. Selected case studies will be presented to exemplify the concepts covered throughout the course.
Mission Statement
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