Pharsight to Present on IVIVC at Bioequivalence & Bioavailability Strategies Conference
June 23 2008 - 6:30AM
PR Newswire (US)
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. DATASOURCE: Pharsight Corporation CONTACT: Investors,
Douglas Sherk or Matthew Selinger, +1-415-896-6820, or Media, Steve
DiMattia or Donald Takaya, +1-646-201-5445, all of EVC Group, for
Pharsight Corporation Web site: http://www.pharsight.com/
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