The Center for Professional Innovation & Education, Costa Mesa, CA
May 17 & 18, 2007
Who Should Attend
This course is specifically designed for personnel in the pharmaceutical and biotechnology industries and 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 development processes. Participants should have some knowledge of these processes and 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. Nonclinical and clinical scientists, managers, and project team leaders at pharmaceutical companies and related industries will gain a detailed understanding of the types of ADME, PK/TK, and DM research studies conducted to support submissions to regulatory authorities. Learning Objectives Upon completing this course, participants will have knowledge of the research studies conducted to characterize the likelihood of success for a drug candidate, either a small organic molecule (NCE) or macromolecule, after administration to animal models and humans. Participants will learn about and understand the requirements for ADME, PK/TK, and DM studies conducted to select the optimal drug discovery lead (developability assessment), to support first-in-human clinical trials, and to compare and extrapolate metabolism profiles from animal models to humans. Course Description The content of this 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, 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 be described in detail.
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