Bioequivalence, Dissolution & IVIVC

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Day 1

14th November

Session 1: Introduction
Session 2: The general requirements for biostudies
Session 3: A dissolution chemists view of drug absorption
Session 4 part I: Establishing the biostudy statistical design
Session 4 part II: Establishing the biostudy statistical design
Session 5: Developing dissolution tests-QA and setting specifications

Day 2

15th November

Session 6: Similarity, comparability and correlation
Session 7: The regulatory requirements as related to product approval and post marketing changes
Session 8: The predictive power of dissolution and alternatives to full bioequivalence
Session 9: Validation and compliance issues

Day 3

16th November

Session 10: General hurdles and pitfalls in bioequivalence studies
Session 11: Some aspects of formulation that can affect bioequivalence and dissolution
Session 12: Where are we going with dissolution and BE Studies