Pharsight to Present On QTc Modeling and Simulation At ACCP Annual Meeting

Dr. T.J. Carrothers Will Present Case Example On the Predictive Value of Pooled Early Phase Concentration-QTc Modeling to Inform Cardiac Risk Assessment of New Drugs


MOUNTAIN VIEW, Calif., Sept. 11, 2008 (GLOBE NEWSWIRE) -- Pharsight Corporation (Nasdaq:PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that T.J. Carrothers, Sc.D., senior scientist, Strategic Consulting Services, will present a scientific poster at the 37th Annual Meeting of the American College of Clinical Pharmacology (ACCP). The ACCP Annual Meeting will be held at the Sheraton Philadelphia City Center Hotel in Philadelphia, Pennsylvania from September 14-16, 2008.

Dr. Carrothers will present a case study, "Performance Characteristics of Pooled Early Phase Concentration-QTc Modeling," on September 15 as part of a conference poster session. Dr. Carrothers' presentation uses modeling and simulation to explore the predictive performance of pooled concentration-QTc (C-QT) modeling from early clinical studies in the assessment of the cardiac proarrhythmic risk of new drugs.

"Model-based approaches provide important tools in the analysis of QT data, which is now required by the FDA for all new drug submissions," said John E. Murphy, DrPH, senior vice president of Pharsight Consulting Services. "Pooled concentration-QTc modeling approaches based on pre-TQT, Phase I studies that integrate triplicate ECG data over a range of doses offer the potential to make robust predictions of drug effects on QTc based on the totality of the underlying clinical data. At a cost of nearly $50,000 per subject, or more than $2 million for a reasonably sized thorough QT study, the stakes around proper TQT timing and study design are critically high for drug development organizations where scrutiny of the QTc safety signal impacts development, regulatory approval and labeling of every drug in its pipeline. Pharsight is pleased to be invited to ACCP, to share its perspectives on novel concentration-QTc modeling approaches with industry colleagues."

Additional information about ACCP can be found at www.accp1.org.

About Pharsight Corporation

Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. Pharsight's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.

Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available at www.pharsight.com.

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