The course will describe scientific concepts and practice of ADME andtoxicology studies in drug development, including preclinical in vitroand in vivo studies, clinical studies, IND and NDA submissions, andanalytical 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 isolationand identification, and toxicokinetic support, will be discussed. Studydesigns and possible interpretations of results and representative casestudies will be presented. The generation of study protocols, studyreports and data summaries for the purpose of submission toregulato ry authorities will be delineated. This course is specifically designed for personnel in the pharmaceuticaland 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) andtoxicology during the discovery, lead-optimization, IND and NDA-enabling drug development processes. Participants should have some know ledge of these processes anddesire to learn more about how ADME, bioanalysis, PK/TK, and DMstudies are designed, conducted, and interpreted in order tocharacterize the fate of a drug candidate. Nonclinical and clinicalscientists, project managers, and study team leaders at pharmaceutical companies and related industries will gain a detailedunderstanding of the types of safety/toxicology, ADME, bioanalysis,PK/TK, and DM research studies required to support submissions to regulatory authoritiesFor more inquiries contact cristina (at) mondialresearchgroup.com