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Using Pharmacokinetic and Pharmacodynamic Principles to Enable IND and NDA Submissions

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Overview 

When it comes to submitting an IND or NDA to the FDA, there are many scientific criteria that need to be met as well as a thorough understanding of clinical pharmacology and pharmacokinetic concepts and regulatory requirements. The agenda for this course is structured based on the building blocks for the Clinical Pharmacology reviewing discipline and associated FDA guidelines. This course brings together faculty from both industry and FDA to share strategies for compliance with biopharmaceutic and pharmacokinetic requirements to successfully file an IND and NDA. This course will allow ample time for questions and interaction with industry and FDA representatives.

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