Event:
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Introduction to Bioequivalence and Therapeutic Equivalence
- Hosted By:
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ComplianceOnline
- Start:
- Wednesday - Jun 26, 2013 10:00 AM
- End Time:
- Wednesday - Jun 26, 2013 11:00 AM
- Location:
- Online
- This webinar on bioequivalence will use a case study approach to explore the regulatory issues relevant to the approval of medications designed to be bioequivalent with already-marketed drugs. It covers current regulatory definitions, requirements and relative exceptions to bioequivalency and therapeutic equivalency.
Why Should You Attend:
This webinar will explore the regulatory issues relevant to the approval of medications designed to be bioequivalent with already-marketed drugs. In addition to reviewing the regulatory definitions of bioequivalence, pharmaceutical equivalence and therapeutic equivalence, the program will review approval requirements for drugs in special categories, including critical dose drugs and modified release products. Finally, selected examples of compliance and non-compliance with FDA policies will be discussed.
The program will review case studies of critical dose drugs with a narrow therapeutic window and products undergoing re-formulation as modified release products, and the FDA's Orange Book coding for bioequivalence, discussing potential approval and marketing implications. Examples of compliance and non-compliance with FDA requirements will be presented.
Learning Objectives:
By the completion of this program, participants will be able to
- Identify the FDA requirements for a successful ANDA by demonstrating bioequivalence for drug products
- Describe the relationships among bioequivalence, pharmaceutical equivalence and therapeutic equivalence
- Interpret the FDA Orange Book coding of equivalence
- Discuss the equivalency considerations for critical dose and modified release pharmaceutical products
- Website:
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