Dr. Timothy Carrothers Will Present Case Example on the Value of Modeling
and Simulation to Assess Potential for QTc Prolongation
MOUNTAIN VIEW, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that Timothy Carrothers, Sc.D., senior scientist, Strategic Consulting Services, has been invited to speak to members of the pharmaceutical and biotechnology industries attending the 2nd Annual Drug Information Association (DIA) Cardiac Safety Conference, to be held in Prague, Czech Republic at the Dorint Praha Don Giovanni Hotel from December 3-4, 2007.
Dr. Carrothers will present a case study on the value of model-based approaches to assess drug effects on QTc prolongation and develop future clinical studies required for new drug approval. Dr. Carrothers' presentation, "Concordance Between the Exposure-QTc Response Relationship in the Pooled Phase 1 Data vs. Thorough QTc Study", is part of a dedicated conference session led by pharmaceutical sponsors and regulators on modeling the relationship between plasma concentration of a drug and its effect on QTc prolongation as an indicator of cardiac arrhythmic risk. The session speakers will present applied research on concentration-QTc modeling and discuss perspectives for its contribution to decisions on the development, regulatory approval and labeling of new drugs. A panel discussion will also provide a forum for scientific discussion and collaborative exchange on exposure-QTc response modeling. Additional information can be found at http://www.diahome.org.
"Model-based approaches provide important tools in the analysis and reporting of QT data, which is now required by the FDA for all new drug submissions to support more informed decision-making," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "These predictive approaches integrate data across a variety of studies, allowing assessment of drug effects on QTc based on the totality of the underlying clinical data, and support trial design of QTc studies. Our scientists' collective experience with modeling QTc prolongation as an important and intensively studied measure of cardiac safety risk spans multiple indications and drug classes. Pharsight is pleased to be invited to the DIA Safety Conference, to share its perspectives on QTc modeling with industry colleagues and to exchange information on emerging trends in cardiac safety and risk assessment."
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 http://www.pharsight.com.
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Pharsight is a registered trademark of Pharsight Corporation. All other brand or product names mentioned in this documentation are trademarks or registered trade marks of their respective companies or organizations.
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