Clarinex®: The Hunt for the Unproducible Metabolite
A HUREL video white paper presented by Ronald E. White, Ph.D. Formerly Vice President of Drug Metabolism at the Schering-Plough Research Institute, Dr. White was directly engaged in the pre-clinical development of desloratadine (Clarinex®), the second-generation drug that Schering developed to follow its blockbuster medication, loratadine (Claritin®). Dr. White’s case study traces the research challenges Schering faced in attempting to answer the FDA’s questions about 3-hydroxy desloratadine, a circulating metabolite which in vitro models then available to Schering were unable to generate but which the HUREL human micro liver model was shown to produce successfully. It also comments on how a correctly predictive in vitro tool like HUREL micro livers might have effected the economics of the commercial launch of Clarinex®.
Interspecies Comparison of DMPK Endpoints
In this video, Dr. Leslie Benet discusses how HUREL micro liver models can be used as artificial tissue constructs to compare interspecies DMPK endpoints between Human, Rat and Dog.