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HomeEventsCourse: Active Pharmaceutical Ingredient (API) and Drug Product Specifications

Course: Active Pharmaceutical Ingredient (API) and Drug Product Specifications - Berlin, Germany

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Germany | 12 December 2012 - 14 December 2012

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.

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This event is published by The Center for Professional Innovation & Education, Inc.

Training for Pharmaceutical, Biotechnology and Medical Device Professionals

As the global leader in accredited biotech, biopharmaceutical, medical device and pharmaceutical training, The Center for Professional Innovation & Education ...

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