Professor University of Maryland baltimore, Maryland
Medications, including modified-release (MR) drugs, typically are available in several strengths. For several reasons, for proposed oral MR generics, it is generally desirable to conduct an in vivo bioequivalence study at the highest strength and seek a biowaiver for lower strengths. Of course, there are several considerations in allowing such biowaivers, which have not been well discussed in the literature. This presentation will discuss results of a survey of pharmaceutical scientists about when it may be appropriate or not appropriate to provide lower strength biowaivers of proposed generic oral MR products. The survey concerned 17 scenarios, where volunteers were asked if a biowaiver was appropriate. Results point towards differences in opinion about the meaning, role, or relevance of: dose proportionality of reference across reference product strengths, proportional similarity, and dissolution similarity between test and reference. Findings may provide insights into potential research directions for formulation understanding of oral MR products.
Learning Objectives:
Upon completion, participant will be able to identify situations when pharmaceutical scientists believe it is appropriate, or not appropriate, to provide lower strength biowaivers of proposed generic oral MR products.
Upon completion, participant will be able to recognize differences in opinion about the meaning, role, or relevance of key terms and concepts, related to lower strength biowaivers of proposed generic oral MR products.
Upon completion, participant will be able to strategize an approach for lower strength biowaivers of proposed generic oral MR products.
