Talk Will Cover the Use of Pharsight Software for In-Vitro / In-Vivo
Correlation Modeling in Drug Development
MOUNTAIN VIEW, Calif., June 23 /PRNewswire-FirstCall/ -- Pharsight(R) 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 Dissolution Testing, Bioequivalence & Bioavailability Strategies Conference, to be held in London, United Kingdom, by Visiongain, at The Grosvenor -- Victoria Hotel, June 26th and 27th, 2008.
Mr. Chittenden will give a lecture on the use of Pharsight's software for in-vitro/in-vivo correlation (IVIVC) and its benefits in formulation design, bioequivalence, and development of dissolution specifications. 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 formulations.
"Doing dissolution analyses with IVIVC is a fast and inexpensive method for obtaining optimal formulations as opposed to slow, expensive bioavailability or bioequivalence (BA/BE) studies that provide hit or miss results," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "Pharsight's IVIVC Toolkit(TM) for WinNonlin(R) guides researchers to perform the right BA/BE studies and eliminate many that are unnecessary. With an average NDA having 3-6 BA/BE studies, avoiding just one unnecessary BA/BE study using the IVIVC Toolkit can easily yield a financial return of 12 to 1."
About IVIVC Toolkit(TM) for WinNonlin(R)
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 http://www.pharsight.com.
Forward Looking Statements
The statements in this press release related to the design and performance of the Pharsight public-source meta-database offering are forward looking statements. Forward-looking statements are inherently speculative, and actual results may differ materially from Pharsight's expectations due to a variety of factors, including: changes in FDA regulations may affect the demand for the product; and customers may not perceive the benefits of the product 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-Q filed with the Securities and Exchange Commission on February 14, 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 are trademarks or registered trademarks of Pharsight Corporation. All other brand and product names are trademarks or registered trademarks of their respective holders.
|SOURCE Pharsight Corporation|
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