Ashish A Mungantiwar
President Medical Services in Macleod’s Pharmaceuticals Limited
Title: Bioequivalence inspection
Biography
Biography: Ashish A Mungantiwar
Abstract
Statement of the Problem: Bioequivalence study is conducted on healthy volunteer/patient to compare pharmacokinetic parameter of test product and reference product. Generic company conducting/sponsoring the study should be aware of risks of rejection and non-compliance.
Methodology & Theoretical Orientation: Current topic will cover list of inspection findings from various regulatory agencies like US, EU and WHO and How to be ready for unannounced inspection, Presentation will discuss current inspection trends and queries asked during dossier assessment.
Conclusion & Significance: This presentation will critically review inspector and assessors expectation on Bioequivalence studies. Understanding such expectation will help for early and successful approval of the product.