Pharsight to Present at DIA Cardiac Safety Conference on December 4, 2007
Dr. Carrothers will present a case study on the value of model-basedapproaches to assess drug effects on QTc prolongation and develop futureclinical studies required for new drug approval. Dr. Carrothers' presentation,"Concordance Between the Exposure-QTc Response Relationship in the PooledPhase 1 Data vs. Thorough QTc Study", is part of a dedicated conferencesession led by pharmaceutical sponsors and regulators on modeling therelationship between plasma concentration of a drug and its effect on QTcprolongation as an indicator of cardiac arrhythmic risk. The session speakerswill present applied research on concentration-QTc modeling and discussperspectives for its contribution to decisions on the development, regulatoryapproval and labeling of new drugs. A panel discussion will also provide aforum for scientific discussion and collaborative exchange on exposure-QTcresponse modeling. Additional information can be found athttp://www.diahome.org.
"Model-based approaches provide important tools in the analysis andreporting of QT data, which is now required by the FDA for all new drugsubmissions to support more informed decision-making," said Shawn O'Connor,president, CEO, and chairman of Pharsight. "These predictive approachesintegrate data across a variety of studies, allowing assessment of drugeffects on QTc based on the totality of the underlying clinical data, andsupport trial design of QTc studies. Our scientists' collective experiencewith modeling QTc prolongation as an important and intensively studied measureof cardiac safety risk spans multiple indications and drug classes. Pharsightis pleased to be invited to the DIA Safety Conference, to share itsperspectives on QTc modeling with industry colleagues and to exchangeinformation on emerging trends in cardiac safety and risk assessment."
About Pharsight Corporation
Pharsight Corporation develops and markets integrated products andservices that enable pharmaceutical and biotechnology companies to achievesignificant and enduring improvements in the development and use oftherapeutic products. Pharsight's goal is to help customers reduce the time,cost and risk of drug development, as well as optimize the post-approvalmarketing and use of pharmaceutical products.
Pharsight's approach enhances the fundamental element of drug developmentsuccess: strong decision-making. By adopting the Pharsight approach, customersacquire a new decision-making process with the potential to systematicallyimprove 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.
Registered Trademarks and Trademarks
Pharsight is a registered trademark of Pharsight Corporation. All otherbrand or product names mentioned in this documentation are trademarks orregistered trade marks of their respective companies or organizations.
SOURCE Pharsight Corporation
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