Dr. Gobburu to Discuss the Impact of Pharmacometrics on Drug Approvals in Rosa's "Impact" Webinar Series

Dr. Gobburu will present "Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions" March 20, 2012. End Quote

(1888PressRelease) March 15, 2012 - Rosa & Co. LLC today announced that Dr. Joga Gobburu, University of Maryland, Baltimore, will present a webinar "Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions" on Tuesday, March 20, 2012 at 1:00 to 2:00 pm EST as part of Rosa's ongoing monthly public webinar series. The purpose of the series, "Impact of Modeling & Simulation in Drug Development", is to foster the use of Modeling and Simulation (M&S) activities in biotechnology, pharmaceutics, and other life science industries. This series is geared to illustrate the advantages and applicability of M&S in product discovery, development, and marketing programs.

Dr. Gobburu will present the results from his recent paper, "Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008." "Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions. Pharmacometrics is defined as a science that quantifies drug, disease and trial information to aid drug development, therapeutic decisions and/or regulatory decisions. In this report, we present the results of a survey evaluating the impact of pharmacometric analyses on regulatory decisions for 198 submissions during the period from 2000 to 2008. Pharmacometric review of NDAs included independent, quantitative analyses by FDA pharmacometricians, even when such analysis was not conducted by the sponsor, as well as evaluation of the sponsor's report. During 2000-2008, the number of reviews with pharmacometric analyses increased dramatically and the number of reviews with an impact on approval and labelling also increased in a similar fashion. We also present the impact of pharmacometric analyses on selection of paediatric dosing regimens, approval of regimens that had not been directly studied in clinical trials and provision of evidence of effectiveness to support a single pivotal trial. Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making." Clin Pharmacokinet. 2011 Oct 1;50(10):627-35.

Register for this free webinar at www.rosaandco.com/webinar. After registering, a confirmation email will be sent with directions for joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at www.rosaandco.com/webinar.

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