Richard H. Guy, University of Bath (U.K.)
My name is Richard Guy. I am Professor of Pharmaceutical Science at the University of Bath in the UK. Since 2013, my research has been funded by the FDA’s Office of Generic Drugs to develop and validate methods to assess the bioequivalence of topical drug products.
My lecture will review the EMA’s “Draft guideline on quality and equivalence of topical products” and I will examine three regulatory-related hypotheses:
- That the assessment of topical bioequivalence can be accomplished using appropriately selected in vitro and/or in vivo surrogate tests.
- That all surrogate tests have limitations but that they do not all have the same limitations; it follows that the results of one test complement those of another.
- That the tests chosen depend on the complexity of the formulation.