The Importance of Full Correct Prediction of Human Metabolites in Discovery and Preclinical Development
"Clarinex®: The Hunt for the Unproducible Metabolite" a Hurel Corporation 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 HµRELhumanTM model was shown to produce successfully. It also comments on how a correctly predictive in vitro tool like Hurel might have effected the economics of the commercial launch of Clarinex®. The video runs about four minutes.