ADME PK/TK and Drug Metabolism in Drug Discovery and Development

Venue: London, UK

Location: London, UK, Belgium

Event Date/Time: Nov 04, 2010 End Date/Time: Nov 05, 2010
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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/toxicokinetics (PK/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 the 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.
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 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, 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