MOUNTAIN VIEW, Calif., July 10, 2008 (PRIME NEWSWIRE) -- Pharsight Corporation (Nasdaq:PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that Jason Chittenden, MS, Director of Training and Pre-Sales will speak to members of the pharmaceutical and biotechnology industries attending the 35th Annual Meeting and Exposition of the Controlled Release Society, to be held at the New York Hilton in New York City, July 13th-16th, 2008.
Mr. Chittenden will give a lecture on the use of in vitro-in vivo correlation (IVIVC) in the development of a model compound with release rate specific bioavailability. Understanding and controlling the relationship between in vitro release and in vivo response in a compound plays a critical role in the development of modified-release formulations, generics, fixed-dose combination products, and drug delivery systems. The earlier in the drug development process IVIVC is implemented, the easier and more cost effective it is to implement all future changes in dissolution profiles.
"New formulations may be needed at various times throughout a drug's life cycle because of changes in manufacturing, taste considerations, changes in route of administration, dosing, or other factors," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "Without IVIVC, each new formulation requires a bioavailability/bioequivalence (BA/BE) study to ensure that the pharmacokinetic profile is acceptable. Pharsight's IVIVC Toolkit(tm) for WinNonlin(r) improves product quality by perfecting formulations through multiple formulation iterations without costly and time consuming BA/BE studies potentially shortening the time to market by up to 3 months for each BA/BE study that is avoided."
About IVIVC Toolkit for WinNonlin
The IVIVC Toolkit for WinNonlin expands the capabilities of WinNonlin, enabling the use of WinNonlin for in vitro-in vivo correlations (IVIVC). The Toolkit brings enhanced deconvolution methods, numerical convolution, plotting capability, and the "IVIVC Wizard" to pharmacokineticists and formulators. IVIVC Toolkit speeds development of new formulations, helps reduce bioequivalence test failures, enables the setting of optimal dissolution specs for quality assurance, allows for visualization of the in vitro-in vivo relationship using its plotting features, and allows for easy application of correlations to predict PK from new in vitro data.
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. The company'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 is headquartered in Mountain View, California. Information about Pharsight is available at www.pharsight.com.
Forward Looking Statements
The statements in this press release related to the functionality, performance, and benefits of the IVIVC Toolkit for WinNonlin software are forward-looking statements. Forward-looking statements are inherently speculative, and the actual results and customer's experience may differ materially from Pharsight's expectations due to a variety of factors, including: changes in FDA regulations and customers may not perceive the benefits of the IVIVC Toolkit for WinNonlin to be the same as Pharsight believes them to be. Other risk factors relating to Pharsight are disclosed in the company's most recent Form 10-K filed with the Securities and Exchange Commission on June 30, 2008. All forward-looking statements are based on information available to the company on the date hereof, and the company assumes no obligation to update such statements.
Registered Trademarks and Trademarks
Pharsight, WinNonlin, and IVIVC Toolkit for WinNonlin are trademarks or registered trademarks of Pharsight Corporation. All other brand and product names are trademarks or registered trademarks of their respective holders.