The USP in general, and its Biopharmaceutics Expert Advisory Committee (EAC) in particular, has been at the centre of developing standards and procedures for drug dissolution testing for the past three decades. However, this EAC has been dissolved for the coming cycle (2010-2015) of the USP expert committees. The activities/responsibilities of the now-dissolved EAC have been transferred to a committee for General Chapter on Dosage Forms, with very few members from the earlier EAC. There has been lack of clear information from the USP on this particular change, especially at a time, when the dissolution community is seeking answers for the difficult and frustrating problems related to the drug dissolution testing. Often, these relate to the use of drug dissolution testing for product evaluations and the use and relevance of PVT.
In the absence of clear information and an apparent significantly diminished role in the future, one can only speculate on the possible scenarios. One of those could be that the USP may be reducing its laboratory based activities (research?) in the dissolution area as there has been limited or no success, but rather frustrations, during the past number of years. The USP may be reversing to a more traditional role for setting objective standards based on the contributions from external sources. If this assumption is correct, then the change at the USP may be considered good. This will provide the industry and others to make needed contributions and for the USP an approach for critically evaluating the problems and accepting the solutions.
