FDAAdvisoryCommittee.com March 17, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology Agenda: On March 17, 2010, the committee will discuss and provide comments on the following topics: (1) General scientific issues related to the application of pharmacogenomics in the early stages of drug development. Pharmacogenomics examines the genetic differences that influence a person's responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology approach to drug safety; (3) the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and (4) scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as ``transporters'' and, in turn, the interactions can affect a drug's safety and/or efficacy.
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