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Pharsight Announces Next Generation Release of Trial Simulator 2.0 for Clinical Trial Decision Management.


Business Editors/Health & Medical Writers

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--March 8, 2000

Pharsight Corporation, a science-based company offering software products, information, and consulting services Noun 1. consulting service - service provided by a professional advisor (e.g., a lawyer or doctor or CPA etc.)
service - work done by one person or group that benefits another; "budget separately for goods and services"
 to enable fundamental and enduring improvement enduring improvement (in·durˑ·ing im·prōōv·m  in the development and use of therapeutic drugs, today announced the release of Pharsight(R) Trial Simulator (1) Software that enables the execution of an application written for a different computer environment. Same as emulator.

(2) Software that models the interactions of hypothetical or real-world objects or business processes.
 2.0.

This 'next generation' release provides drug developers with a powerful workbench for optimizing the design and conduct of clinical studies using computer simulation, enabling a more powerful and effective approach to development and design of clinical drug trials.

"In recent years, clinical trials of new drugs have grown more complex, time-consuming and costly, which has produced a bottleneck A lessening of throughput. It often refers to networks that are overloaded, which is caused by the inability of the hardware and transmission lines to support the traffic. It can also refer to a mismatch inside the computer where slower-speed peripheral buses and devices prevent the CPU  in the rate at which new drugs can be brought to market," said Art Reidel, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Pharsight Corporation. "This increasing complexity has also added many variable elements to the clinical testing process that can contribute to failures due to trial design, rather than to the drug itself.

He continued, "The potential impact of these variables on trial design and potential outcome can only be effectively assessed via computer simulation. Using technologically advanced and user-friendly scientific software tools like Pharsight Trial Simulator 2.0 to design better clinical trials and more efficiently analyze experimental results is critical if pharmaceutical companies are to expedite ex·pe·dite  
tr.v. ex·pe·dit·ed, ex·pe·dit·ing, ex·pe·dites
1. To speed up the progress of; accelerate.

2.
 the drug development process overall."

The prior version, Pharsight Trial Designer 1.2, has already been used in the design of more than 75 trials at twelve of the 'top 20' pharmaceutical companies.

Pharsight Trial Simulator 2.0

Pharsight has developed Trial Simulator 2.0 in response to input from the pharmaceutical industry, as well as the company's Scientific Advisory Board. This "next generation" version of Pharsight Trial Simulator includes more than 50 feature enhancements. Users can easily specify attributes such as inclusion/exclusion criteria inclusion/exclusion criteria Clinical research The medical or social reasons why a person may/may not qualify for participation in a clinical trial , distributions of patient population variables, dosing and observation time and compliance variations, lead-in and follow-up periods and much more, expanding the comprehensive pharmacological Pharmacological
Referring to therapy that relies on drugs.

Mentioned in: Pain Management


pharmacological, pharmacologic

pertaining to pharmacology.
 modeling capabilities of this software tool.

Trial Simulator 2.0 provides built-in, robust statistical tools, using an included copy of MathSoft's S-PLUS data analysis and visualization Using the computer to convert data into picture form. The most basic visualization is that of turning transaction data and summary information into charts and graphs. Visualization is used in computer-aided design (CAD) to render screen images into 3D models that can be viewed from all  suite to provide users flexible visual tools and advanced statistics to quickly identify significant trends and discern dis·cern  
v. dis·cerned, dis·cern·ing, dis·cerns

v.tr.
1. To perceive with the eyes or intellect; detect.

2. To recognize or comprehend mentally.

3.
 underlying meaning in the simulated trial data. Pharsight's OEM (Original Equipment Manufacturer) The rebranding of equipment and selling it. The term initially referred to the company that made the products (the "original" manufacturer), but eventually became widely used to refer to the organization that buys the products and  agreement with MathSoft, Inc. has allowed them to include this technology directly in the Pharsight Trial Simulator, greatly simplifying the task of reviewing and analyzing the results of trial simulations.

Scenario analysis Scenario analysis

The use of horizon analysis to project total returns under different reinvestment rates and future market yields.
 tools, added in Trial Simulator 2.0, enable clinical development teams to quickly explore numerous trial design and dosing options and perform powerful "what-if" analyses of possible trial designs. By reviewing a wide range of possible trial scenarios, Trial Simulator 2.0 allows all of the members of the development team, including pharmacologists, pharmacokineticists, clinical project directors and biostatisticians, to collaboratively assess the possible range of outcomes for specific trial designs before the clinical study is actually conducted.

Easy to Use Interface

Pharsight Trial Simulator 2.0 also adds several new features that increase its ease of use. Among these is a drag-and-drop drug model editor, including a real-time graphical display of simulated model results. Users can also now export their optimized trial protocol directly to a Microsoft(R) Word document, including a timeline showing drug dosing and measurement of patient responses. Pharsight's Trial Simulator allows clinical researchers to model and simulate simulate - simulation  decisions ranging from initial drug dosing to the design of complete clinical trials, thus gaining knowledge of drug characteristics and the range of likely trial outcomes.

"Trial Simulator 2.0 is a tool with state of the art mathematical modeling
Note: The term model has a different meaning in model theory, a branch of mathematical logic. An artifact which is used to illustrate a mathematical idea is also called a mathematical model and this usage is the reverse of the sense explained below.
 and statistical capability, specifically designed for drug development. The dynamic graphical model In probability theory, statistics, and machine learning, a graphical model (GM) is a graph that represents independencies among random variables by a graph in which each node is a random variable, and the missing edges between the nodes represent conditional independencies.  building interface facilitates model development. Protocol development in TS 2.0 mimics the process currently used in the industry and the ability to examine "what-if" scenarios should help drug development teams with trial design and decision making. "To maximize its value to drug development, TS 2.0 should be used by experienced and skilled Pharmacometricians with appropriate input from the drug development teams," said Tim Goggin, Clinical Science / Clinical Pharmacology Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world. , at F. Hoffmann-La Roche, Basel (CH)."

"We're truly excited to be able to deliver the software tools that drug development scientists are requesting," said Dan Weiner, vice president and general manager of Scientific Products at Pharsight Corporation. "Pharsight Trial Simulator 2.0 offers clinical development teams the power to take control of their projects by gaining a better understanding of how they should conduct clinical trials to maximize their chances of success. Using the Trial Simulator, companies can predict the potential range of results of proposed trials before R&D dollars are committed to further development of a drug, and human subjects are exposed to experimental therapies."

Price and Availability

The Pharsight Trial Simulator 2.0 is available now. The basic software license is priced at $15,000 per client and $25,500 for access over a company's network. There is an annual renewal license fee equivalent to 30% of the license price.

About Pharsight Corporation

Pharsight's mission is to enable the pharmaceutical industry to make better drug development decisions, thereby developing more competitive drugs faster and at lower cost for today's competitive environment. Pharsight employs a mathematical and scientific approach to better understand the biological implications of new drug development, marrying pharmaceutical science, clinical development and information technology in its efforts to facilitate decision-making by pharmaceutical developers. Pharsight's leadership and technology provides the potential for pharmaceutical industry executives to meaningfully utilize e-R&D and business-to-business Internet strategies in the drug development process. Pharsight Corporation is headquartered in Mountain View, Calif. Information about Pharsight Corporation is available on the Worldwide Web at http://www.pharsight.com.
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Date:Mar 8, 2000
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