Impact of Pharmacometrics on Boceprevir and Telaprevir Approvals and HCV Clinical Care

Boceprevir and telaprevir are novel, direct-acting drugs for hepatitis C treatment recently approved by the FDA for use in patients. Using novel pharmacometric methods, including disease progression and PK/PD modeling, the drugs were approved for use in patient populations and at drug dosages that had not been directly tested in clinical trials. Join the Pharmacometrics Core and the NC TraCS Institute for a Lunch’n’Learn* seminar with Dr. Pravin Jadhav, Pharmacometrics Team Leader at the U.S. Food and Drug Administration, and Dr. Michael Fried, Director of the UNC Liver Center in a discussion of the approaches used by the FDA to grant approval and the clinical impact of these drugs.

When Oct 13, 2011
from 12:00 PM to 01:00 PM
Where Brinkhous-Bullitt, Room 219
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