Navigation Links
Pharsight Uses FDA Disease Model to Support Oncology Drug Development
Date:11/20/2007

Use of FDA Model in Non-Small Cell Lung Cancer Expected to Inform

Quantitative Predictions for Experimental Cancer Treatment

MOUNTAIN VIEW, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Pharsight Corporation (OTC Bulletin Board: PHRS), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that its Strategic Consulting Services Group is using a quantitative disease model developed by the Food and Drug Administration (FDA) for non-small cell lung cancer (NSCLC) to support an oncology drug development program sponsored by one of its clients, a global pharmaceutical company.

Pharsight scientists are using FDA's publicly available model in NSCLC to perform simulations of expected survival based on tumor shrinkage for an investigational drug in early clinical studies. Pharsight scientists also expect to refine these simulations with emerging data in new clinical studies to assist with key oncology development program decisions, including optimized dose selection and improved design of survival trials.

Pharsight's collective modeling and simulation experience in oncology includes longitudinal exposure-response modeling to inform labeling decisions and test dosing strategies, allometric projections, and work with novel mechanisms.

FDA has developed several quantitative drug-disease models based on the literature and clinical trial data from sponsor submissions for drug approval. FDA does not release proprietary source data from sponsors used to develop and validate the models, but the agency has underscored its commitment to publicly sharing and further testing the models that it has developed in important disease areas, including oncology. The NSCLC model was presented by FDA scientists at a January 2007 meeting, co-sponsored by FDA and the Drug Information Association (DIA), entitled "Sharing Knowledge to Improve Clinical Drug Development and Regulator
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
2. Kosans Motilin Receptor Agonist, Licensed to Pfizer, Enters Phase 1 Clinical Trial in Gastroesophageal Reflux Disease
3. Avicena Scientific Collaborator Advances Program for Using Energy Enhancing Molecules to Treat Neuromuscular Diseases
4. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
5. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
6. Baxter and The Alzheimers Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimers Disease
7. Four Analyses of Three-Year Clinical Data Suggest CYPHER(R) Sirolimus-Eluting Coronary Stent May Provide Alternative to Surgery for Patients with Multivessel Disease
8. Peregrine Researchers Report Data Showing Bavituximabs Potential to Shrink Human Prostate Tumors in Model of Relapsed Disease
9. Public Forum to Discuss Addiction as a Treatable Disease and Highlight National Alcohol and Drug Addiction Recovery Month
10. K-State Researchers Bringing Expertise to Kansas City Symposium on Disease and National Security
11. Genta Initiates First Clinical Trial with New Oral Drug (G4544) to Treat Bone Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... WESTBROOK, Maine, July 25, 2014  IDEXX Laboratories, Inc. ... for the second quarter of 2014 increased 11% versus ... growth 1 for the second quarter of 2014 ... normalized for changes in distributor inventory 2 . Earnings ... 30, 2014 increased 11% from the prior year period ...
(Date:7/25/2014)... July 25, 2014  Semler Scientific, Inc. (Nasdaq: ... risk assessment company that develops patented products that ... chronic diseases, today reported financial results for the ... 2014. "The second quarter of ... Doug Murphy-Chutorian , M.D., chief executive officer ...
(Date:7/25/2014)... Ill., July 25, 2014 NOT FOR ... OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO ... OR REGULATIONS OF SUCH JURISDICTION AbbVie (NYSE: ABBV ... June 30, 2014. "This was another very ... per share above our original guidance and announced plans to ...
Breaking Medicine Technology:IDEXX Laboratories Announces Second Quarter Results 2IDEXX Laboratories Announces Second Quarter Results 3IDEXX Laboratories Announces Second Quarter Results 4IDEXX Laboratories Announces Second Quarter Results 5IDEXX Laboratories Announces Second Quarter Results 6IDEXX Laboratories Announces Second Quarter Results 7IDEXX Laboratories Announces Second Quarter Results 8IDEXX Laboratories Announces Second Quarter Results 9IDEXX Laboratories Announces Second Quarter Results 10IDEXX Laboratories Announces Second Quarter Results 11IDEXX Laboratories Announces Second Quarter Results 12IDEXX Laboratories Announces Second Quarter Results 13IDEXX Laboratories Announces Second Quarter Results 14IDEXX Laboratories Announces Second Quarter Results 15IDEXX Laboratories Announces Second Quarter Results 16IDEXX Laboratories Announces Second Quarter Results 17IDEXX Laboratories Announces Second Quarter Results 18IDEXX Laboratories Announces Second Quarter Results 19IDEXX Laboratories Announces Second Quarter Results 20IDEXX Laboratories Announces Second Quarter Results 21IDEXX Laboratories Announces Second Quarter Results 22IDEXX Laboratories Announces Second Quarter Results 23IDEXX Laboratories Announces Second Quarter Results 24IDEXX Laboratories Announces Second Quarter Results 25IDEXX Laboratories Announces Second Quarter Results 26IDEXX Laboratories Announces Second Quarter Results 27IDEXX Laboratories Announces Second Quarter Results 28IDEXX Laboratories Announces Second Quarter Results 29IDEXX Laboratories Announces Second Quarter Results 30IDEXX Laboratories Announces Second Quarter Results 31IDEXX Laboratories Announces Second Quarter Results 32IDEXX Laboratories Announces Second Quarter Results 33IDEXX Laboratories Announces Second Quarter Results 34Semler Reports Second Quarter 2014 Financial Results 2Semler Reports Second Quarter 2014 Financial Results 3
... Oct. 5 The Thompson Group of Companies announced ... (AIT), a Hamilton Sundstrand Corporation business. AIT will ... Group. Financial terms of the purchase were not disclosed. ... manufacture and marketing of process analytical instruments including Analect ...
... CITY, Oct. 5 Orthopedics This Week , a ... Awards for Best New Technology for Spine Care in ... implant and instrument manufacturer focused on unique silicon nitride (SiN) ... in Biomaterials category for its Valeo® AL Lumbar Spacer ...
Cached Medicine Technology:Thompson Group Acquires Hamilton Sundstrand's Applied Instrument Technologies 2Two Amedica®/US Spine® Implant Products Receive Best New Technology Awards from Orthopedics This Week 2
(Date:7/25/2014)... (HealthDay News) -- Unlike children, the vast majority of adults ... at mealtime, according to a new study. This ... not just Americans, researchers from Cornell University revealed. They ... or improve their eating habits make better choices. "If ... stomach," researcher Brian Wansink, director of the Cornell Food ...
(Date:7/25/2014)... 2014 (HealthDay News) -- Although cervical cancers are declining ... to human papillomavirus (HPV) are increasing, a new study ... base of the tongue and tonsils have increased over ... younger than 45, the Canadian researchers report. "The ... younger men and of anal cancer among younger women ...
(Date:7/25/2014)... that controls when genes are switched on or off ... brain to regulate metabolism, UT Southwestern Medical Center researchers ... therapies to treat obesity and diabetes, since the transcription ... appears to influence the body,s sensitivity to insulin ... to the body,s regulation of food intake and sugar ...
(Date:7/25/2014)... NH (PRWEB) July 25, 2014 Innerspire, ... has joined the company as a Creative Enrollment Specialist. ... extensive relationship building skills as well as his accomplished ... of small business clients, and to service the creative ... Additionally, Greg will work with small business owners ...
(Date:7/25/2014)... American Brain Tumor Association (ABTA) today unveiled branding of ... patient and family conference in Chicago. , “This is ... we – the first and now only national organization ... tumor research – extend our reach by engaging volunteers ... our materials and services into the hands of those ...
Breaking Medicine News(10 mins):Health News:Most Adults Are Members of 'Clean Plate Club' 2Health News:Anal, Throat Cancers on the Rise Among Young Adults, Study Finds 2Health News:Manipulating key protein in the brain holds potential against obesity and diabetes 2Health News:Innerspire, LLC Continues National Expansion 2Health News:Innerspire, LLC Continues National Expansion 3Health News:Innerspire, LLC Continues National Expansion 4Health News:American Brain Tumor Association Unveils Brand Identity for Newly Launched Volunteer Network 2Health News:American Brain Tumor Association Unveils Brand Identity for Newly Launched Volunteer Network 3
... Include 24-oz and Convenient 4-oz Travel Size Spray ... PURE ) today announced an agreement ... silver dihydrogen citrate (SDC)-based disinfectant as OneShot Plus(TM) ... Plus product line. OneShot Plus DD eliminates ...
... retire from BoardNATICK, Mass., March 2 Boston Scientific Corporation ... Board of Directors has elected John E. Sununu as a ... as a U.S. Senator from New Hampshire. He was ... Foreign Relations, and he was appointed the Congressional Representative to ...
... no harm -- from TV viewing by young children, , , MONDAY, ... a shelf full of videos claiming to be educationally stimulating for ... wallet. , A new study suggests that watching television won,t ... several hours a day. , "TV, in and of itself, ...
... Officially Launched to Provide Consumers a Free-of-Charge ... from Funeral Homes, Cremation Services and Cemeteries ... http://www.FuneralDecisions.com ) has announced the official launch ... tool for individuals seeking funeral, cremation, and ...
... System Cart Allows Easier Operation and Improved Workflow ... Traxtal Inc., the pioneer and world leader in ... newly designed system cart for the PercuNav interventional ... Booth # 322 of the Society of Interventional ...
... March 2 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. ... today announced that the Company has amended the ... facility with Valens U.S. (formerly Laurus Master Funds). ... agreed to a near-term extension of this facility, ...
Cached Medicine News:Health News:Sterifide Laboratories to Launch 'Powered by SDC' OneShot Plus Disinfectant and Deodorizer 2Health News:Sterifide Laboratories to Launch 'Powered by SDC' OneShot Plus Disinfectant and Deodorizer 3Health News:Sterifide Laboratories to Launch 'Powered by SDC' OneShot Plus Disinfectant and Deodorizer 4Health News:Boston Scientific Announces Election Of John Sununu To Its Board Of Directors 2Health News:Boston Scientific Announces Election Of John Sununu To Its Board Of Directors 3Health News:Boston Scientific Announces Election Of John Sununu To Its Board Of Directors 4Health News:TV Watching Doesn't Fast-Track Baby's Skills 2Health News:TV Watching Doesn't Fast-Track Baby's Skills 3Health News:Taking the Stress Out of Funeral Planning, FuneralDecisions.com Offers Consumers an Innovative Approach 2Health News:Traxtal to Introduce Next-Generation PercuNav System Cart at SIR Annual Scientific Meeting 2Health News:Bioniche Revolving Credit Facility Maturity Date Amended 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: