WS Local BE image 

Cosponsored with GPhA cosponsor logo 

Held in conjunction with the 2016 AAPS Annual Meeting and Exposition. 

Background

The demonstration of bioequivalence for locally acting drugs, for which the site of action is at or near the site of application and upstream from the systemic circulation, has frequently posed some of the greatest challenges in bioequivalence. Historically, extremely expensive clinical endpoint bioequivalence studies have generally been the centerpiece of bioequivalence assessments for such products. In addition to the high cost and difficulty associated with such clinical endpoint studies, they are notoriously insensitive toward formulation differences. Although these problems have plagued those firms seeking to develop a variety of different dosage forms, three of the most problematic routes of administration have been topical (dermatological), ocular, and inhalation. The vast majority of publications and public meetings addressing bioequivalence for products administered via these three routes have focused narrowly on a single route of administration. However, there are many challenges that are common to the development of alternative bioequivalence strategies of products administered via these three non-oral routes.

Goals

This workshop seeks to bring together the latest research and thinking from these three fields to explore the possibilities of developing more unified, totality of evidence-based approaches toward the demonstration of bioequivalence for these products in ways that significantly reduce the clinical burden.

Who Should Attend

This workshop will be of particular interest to scientists in preclinical and clinical development, interested in branded and generic small molecule therapeutic drug products. Particularly relevant for small to medium size companies who are trying to enter the space of locally acting drug products.