ADME, PK/TK, and Drug Metabolism in Drug Discovery and Develop

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

The content of this overview course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed.

Study designs and potential results along with possible interpretations from each of the study types will be presented. The generation study reports and summaries, both of which are to be included in submissions to regulatory authorities for completed research experiments, will also be discussed.

Who Should Attend

This three-day overview course is specifically designed for personnel in the pharmaceutical and biotechnology industries, as well as, contract research organizations (CROs) who need to understand the requirements for ADME (absorption, distribution, metabolism, elimination), pharmacokinetics (PK) and toxicokinetics (TK), and drug metabolism (DM) experiments during the drug discovery and the preclinical/nonclinical and clinical development processes.

Those attending this training should have some knowledge of the aforementioned processes, as well as, a desire to learn more about how ADME, PK/TK, and DM studies are designed, conducted, and interpreted in order to characterize the fate of a drug candidate in the body. Nonclinical and clinical scientists, managers, and project team leaders at pharmaceutical companies and related industries will gain a basic understanding of the types of ADME, PK/TK, and DM research studies conducted to support submissions to regulatory authorities.