'Equivalence is Different' - Some Comments on Therapeutic Equivalence

摘要

It is a pleasure to be invited to comment on this set of papers, which is an impressive collection of current thinking on both sides of the regulatory divide as well as from interested academic third parties. At the time of writing the pharmaceuticalindustry and also the drug regulatory agencies are the subject of unpleasant criticisms (in my view largely mistaken) regarding standards of proof of efficacy and safety. As these papers clearly illustrate, however, such issues are taken very seriously indeed by those who work directly or indirectly in drug development and the science of drug regulation consists of an unending and vigorous debate on approaches to evidence and proof. In the general spirit of this debate, I have decided to be critical ofthe individual contributions and pick out debatable points, I hope that the contributors will forgive me for not dwelling overlong on the many excellent, sensible and uncontroversial points they make.