B11 – Bioequivalence from Three Perspectives

Bioavailability and bioequivalence are fundamental elements of pharmaceutical product development, linking the formulations proposed for commercialisation with those used during the clinical trials.  In order to give attendees a great insight into how these studies are conducted, evaluated and the results interpreted, this session will look at bioequivalence studies from three different perspectives.  Presentation one will be from the perspective of the clinical research centre and will cover the key elements of study design, patient recruitment, drug dosing and blood collection and analyses, including examples of different study designs.  The second presentation will describe the perspective of the TGA evaluator and will focus on the areas that receive specific attention during assessment, using detailed discussion on real case studies where bioequivalence was of specific concern.  The final presentation will look at bioequivalence results from a clinical perspective, focusing on where the data is imperfect.  Again using real case examples, the discussion will cover how the clinical impact of potentially bio-inequivalent products is determined and how regulatory professionals can identify and address concerns.

 

Chairperson: Robert Stringer, Managing Director Capital K Consulting