Event Date/Time: Mar 22, 2012
End Date/Time: Mar 23, 2012
The content of this course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADMET, PK/TK, and DM program that is conducted within a drug development logic plan and in compliance ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, appropriate use of in vitro and in vivo mechanistic toxicity assays and their relationship with regulatory toxicology, animal and human pharmacokinetics,
protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed. Case studies of well and poorly designed programs,study designs and potential results, with possible interpretations, from each of the study types will be presented.