Mondial Research Group, Boston, Massachussets
20th-21st March 2014
The course will describe scientific concepts and practice of ADME and toxicology studies in drug development, including preclinical in vitro and in vivo studies, clinical studies, IND and NDA submissions, and analytical chemistry. The content of this course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well designed and successful drug development program, conducted in accordance with current best practices and in compliance with regulatory guidelines. Various disciplines including safety, toxicology, in vitro / in vivo metabolism, drug delivery, bioanalysis, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed. Study designs and possible interpretations of results and representative case studies will be presented. The generation of study protocols, study reports and data summaries for the purpose of submission to regulato ry authorities will be delineated. This course is specifically designed for personnel in the pharmaceutical and biotechnology industries and contract research organizations (CROs) who need to understand the state of the art for the evaluation ADME tox drug properties: Absorption, distribution, drug metabolism (DM), elimination, pharmacokinetics/toxicokinetics (PK/TK) and toxicology during the discovery, lead-optimization, IND and NDA -enabling drug development processes. Participants should have some know ledge of these processes and desire to learn more about how ADME, bioanalysis, PK/TK, and DM studies are designed, conducted, and interpreted in order to characterize the fate of a drug candidate. Nonclinical and clinical scientists, project managers, and study team leaders at pharmaceutical companies and related industries will gain a detailed understanding of the types of safety/toxicology, ADME, bioanalysis, PK/TK, and DM research studies required to support submissions to regulatory authorities
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