Bioequivalence and Generic Drug Products: Scientific and Regulatory Considerations
Online via WebEx
The LAU School of Pharmacy’s Professional Development Committee invites you to an engaging session titled Bioequivalence and Generic Drug Products: Scientific and Regulatory Considerations.
Presented by
Sam H. Haidar, Ph.D, R.Ph
Dr. Haidar is the Executive Director of the Lebanese American University’s Pharmaceutical and Medical Research Center (PMRC). Previously. he served as Senior Science Advisor at the US FDA’s Office of Study Integrity and Surveillance. and held various leadership roles in bioequivalence and clinical pharmacology. including Branch Chief. Deputy Director. and Acting Director for the Division of Generic Drugs BE Evaluation. His expertise also includes roles as a Lead Pharmacologist, Pharmacometrics Scientist, and Clinical Pharmacology Reviewer. Dr. Haidar has led FDA-funded research projects on bioequivalence and pharmacokinetics, contributing to over 40 publications and a book chapter. He has represented the FDA in global conferences and collaborative efforts with the EMA, WHO and other international agencies.
Session Learning Objectives
- Provide the regulatory definition of bioequivalence (BE)
- List types of studies acceptable for evaluating BE
- Describe drug absorption and bioavailability
- Characterize the pharmacokinetic (PK) and statistical parameters used to test BE
- List and describe the different components of BE studies
- Name the uses of BE studies
- Address common misconceptions about generic products
- Describe cases where in vivo BE studies can be waived