Navigation Links
FDA and Pharsight Continue to Collaborate Under CRADA
Date:12/11/2007

FDA Modeling and Simulation Infrastructure Now Incorporates Three Pharsight

Products

MOUNTAIN VIEW, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). The CRADA collaboration directly supports FDA's Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.

Since the initiation of the five-year CRADA in June 2006, Pharsight has successfully worked with FDA to install Pharsight(R) Knowledgebase Server(TM) (PKS(TM)) into the Agency's IT environment. PKS is a market-leading, high- productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. Pharsight has conducted training classes for FDA staff on PKS and has also trained FDA staff on WinNonlin(R) and Trial Simulator(TM), which FDA had previously installed. Pharsight has also introduced Drug Model Explorer(R) (DMX(R)) to FDA.

Importantly, Pharsight has worked with FDA to streamline the process of loading data from New Drug Applications (NDAs) into PKS by integrating the FDA's internal data management tools with Pharsight's PKS data connector technology. This integration allows FDA reviewers to build analysis datasets from NDAs submitted in Clinical Data Interchange Standards Consortium (CDISC) and non-CDISC formats. These analysis datasets can then be imported into WinNo
'/>"/>

SOURCE Pharsight Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Pharsight Files Application for Nasdaq Capital Market Listing
2. Pharsight to Host European Software Conference
3. Pharsight Expands Global Consulting Services Teams
4. Pharsight Achieves $7.3 Million in Quarterly Revenue
5. Pharsight to Present at DIA Cardiac Safety Conference on December 4, 2007
6. Battle Continues Over Vietnam PTSD Numbers
7. Continued Statin Use Boosts Post-Stroke Outcomes
8. U.S. Research Funding Continues to Flatten as U.S. Health Costs Climb - in August 31 Science
9. Therap Services Continues to Hire Experienced Developmental Disability Industry Clinicians for its Customer Support Team
10. Securians Minnesota Life Continues to Climb Group Life Rankings
11. USA TODAY Continues Spirit of the USA Charity Program as Part of Newspapers 25th Anniversary Celebration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 11, 2014 As transvaginal mesh ... Johnson & Johnson’s Ethicon Inc. unit continue to ... that the Texas Attorney General’s Office has acknowledged ... surgical mesh products used to treat pelvic organ ... report from kens5.com, the probe began nearly two ...
(Date:7/11/2014)... HealthDay Reporter THURSDAY, July 10, 2014 ... was thought to be cured by immediate and aggressive drug ... the AIDS-causing virus in her bloodstream, disappointed federal officials announced ... had remained virus-free even though she stopped taking HIV medications ... remission would open the door to a functional cure for ...
(Date:7/11/2014)... The report, “Specialty Synthetic Fibers & ... - 2018,” defines and segments the specialty synthetic ... and forecast of the volumes and values of ... meta aramids, UHMW Polyethylene, carbon fiber, partially oxidized ... fiber, PBO fiber, and liquid crystal polymer fiber ...
(Date:7/11/2014)... 11, 2014 Operators and ... billion in fuel costs now that model ... current GHG standards are phasing in ... upon themselves to install new features into ... reduction technologies , 2.    Efficient driveline components which ...
(Date:7/11/2014)... CA (PRWEB) July 11, 2014 Ticket Down ... at the Concord Pavilion . When it comes to the ... Luke Bryan. The 37-year-old Georgia native is one of the biggest ... the entertainment business. Bryan is currently out on his “That’s My ... the many stops the tour will be making through the rest ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 2Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 3Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 4Health News:Mississippi Girl Thought Cured of HIV Shows Signs of Infection 2Health News:Mississippi Girl Thought Cured of HIV Shows Signs of Infection 3Health News:Specialty Synthetic Fibers & Glass Fiber Market Poised to Reach $20.1 Billion at a CAGR of 5.2% by 2018 – Report by MarketsandMarkets 2Health News:Specialty Synthetic Fibers & Glass Fiber Market Poised to Reach $20.1 Billion at a CAGR of 5.2% by 2018 – Report by MarketsandMarkets 3Health News:Specialty Synthetic Fibers & Glass Fiber Market Poised to Reach $20.1 Billion at a CAGR of 5.2% by 2018 – Report by MarketsandMarkets 4Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 2Health News:LeaseQ Agrees the Latest Round of Greenhouse Gas Rules Could Increase the Cost of Truck Acquisition and Maintenance 3Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 2Health News:Luke Bryan Ticket Prices Slashed at Concord Pavilion 3
... Oct. 8 Thousands of people around the world ... poetry and speak out to raise awareness and funds ... on Saturday, October 10, 2009. , "Discovering your Voice," ... 2009, stresses the need to hear the voices of ...
... Quantros, a leading provider of safety and quality ... industry, today announced significant updates to its Regulatory ... coincide with National Hospital Quality Measures (NHQM) updates ... will now include expanded tracking of venous thromboembolism ...
... Sysmex America, Inc. today announced that Tom Lindsay ... Sales. Lindsay will be responsible for sales strategy ... and retention of the company,s sales professionals. ... will focus on cross-functional collaboration that enables Sysmex to ...
... 8 American Laser Centers, the leading provider of aesthetic ... CEO, to oversee the continued growth and national expansion of ... ALC,s board of managers, and is responsible for the strategic ... the role of CEO from James McDermott. , American Laser ...
... The University of Guam received an $8,000,000 five-year ... to support a strong national cancer program aimed ... and the impact on minority populations. The grant ... research capabilities at the University of Guam, Increase ...
... Elsevier, a world-leading publisher of medical information products and ... Medical Press (PUMP) it has donated over 5,000 books ... The initiative is supported by the Development Centre for ... book donation is in line with the spirit of ...
Cached Medicine News:Health News:Discovering the Voice of Hospice and Palliative Care Worldwide: World Hospice and Palliative Care Day - October 10, 2009 2Health News:Quantros Expands RRM Solution With New Quality Measures 2Health News:Sysmex America Names National Sales Director 2Health News:American Laser Centers Names Health Care Veteran Steven Straus CEO 2Health News:University of Guam Cancer Research Center receives $8M grant 2Health News:Elsevier's Health Sciences Division and Peking University Medical Press cooperate on book donation 2
(Date:7/11/2014)... /PRNewswire-iReach/ -- VAPETEK™, Inc. has announced a new ... in portable vaporizers, which contains CBD, or cannabodiol. ... cannabidiol offers consumers a THC-free product made for ... technology. Photo - http://photos.prnewswire.com/prnh/20140711/126344 ... compounds which are currently known, two of which ...
(Date:7/11/2014)... 11, 2014 Patient engagement has become ... organizations are turning to an assortment of marketing ... part of this evolving approach to patient engagement, ... and engage patients throughout their experiences with a ... By mapping the patient journey and employing a ...
(Date:7/11/2014)... , July 11, 2014 The ... are evolving across industry sectors to better identify ... better ways to engage with and understand consumers, ... themselves and make critical purchasing decisions. ... Best Practices, LLC, one area where organizations can ...
Breaking Medicine Technology:VAPETEK Releases CBD-Infused eLiquid For The Consumer Market 2New Study Uses Six-Step Patient Journey as Framework for Consumer-Focused Marketing Opportunities 2New Technologies Transforming Consumer Marketing Research Playbook 2
... treatment initiation and longer exposure to Betaseron ... sclerosis, MONTREAL, Sept. 19 Data ... Research in Multiple Sclerosis (WCTRIMS) demonstrated that,early ... a,greater impact on long-term outcomes, when compared ...
... 19 Novavax, Inc.,(Nasdaq: NVAX ) a clinical-stage ... Chief Executive Officer, will be presenting at,the 2008 UBS ... is being held September 22-25, 2008 at The Grand ... 2008 at 10:30 am.,Eastern Time. Dr. Singhvi will provide ...
Cached Medicine Technology:New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R) 2New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R) 3New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R) 4New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R) 5
... to use instruments for nerve location: our ... stimulator, and muscle locator, together with a ... pencil point needles., ,The RDG Nerve ... to use stimulator, designed to facilitate the ...
... Based on the original MS-III ... electrosurgery certification, enhanced keypad ... ,The MiniStim® MS-IV peripheral ... for neuromuscular monitoring in operating ...
... beyond your investment., ,The Centiva/5 Critical Care ... time demands of the critical care environment. The ... mind combining a compact size with high levels ... valuable space around the patients bed and allows ...
... is combining a lightweight mesh material with the ... hernia plug which stands for a high patient ... material is included in Premilene Mesh LP Self-Forming ... for a softer and less bulky Plug Premilene ...
Medicine Products: