ADMET PK/TK and Drug Metabolism

Charlotte, United States 22 23 March / 2012

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About the training

Course Scope and Description
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 ADMET (absorption, distribution, metabolism, elimination, toxicity),
pharmacokinetics/toxicokinetics (PK/TK) and drug metabolism (DM) experiments during the
drug discovery and development processes.
It would be favorable for participants to have some knowledge of these processes and the
desire to learn more about how ADMET, PK/TK, and DM studies are designed, conducted, and
interpreted in order to characterize the fate of a drug candidate and select the candidate for
preclinical development that meet the set criteria.
Nonclinical and clinical scientists, managers, and project team leaders at pharmaceutical
companies and related industries will gain a detailed understanding of the state-of-the-art in
vitro and in vivo ADMET assays, and how PK/TK, and DM research studies are conducted to
select the candidates for preclinical development and to support submissions to regulatory
authorities. In vitro/in vivo correlations, how to design and use in vitro ADMET studies to get
maximum value out of in vivo studies will be addressed. Appropriate use of validated PBPK
modeling during discovery and development of drug candidates will be discussed.
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. The generation of study reports and summaries, both of which are to be
included in submissions to regulatory authorities, for completed research experiments will be
delineated.
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Location

Address: Charlotte, United States
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