PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: Covance, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Covance Completes Microdose Study Under expIND Pathway - Covance completes
Covance Completes Microdose Study Under expIND Pathway

 

NewswireToday - /newswire/ - Princeton, NJ, United States, 2007/05/23 - Covance completes "cold" microdose study under the exploratory Investigational New Drug (expIND) pathway. NYSE: CVD

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Covance, one of the world's largest drug development services companies, announced that it has recently completed a "cold" microdose study under the exploratory Investigational New Drug (expIND) pathway. Microdose studies, which use a small amount of drug and small cohorts to assess initial pharmacokinetics, can be an important stepping-stone toward expanded development and have the potential to cut time and cost from drug development.

This first-in-human trial, conducted at the Covance Clinical Research Unit in Honolulu on behalf of a major pharmaceutical company, provided pivotal pharmacokinetic (PK) human data only ten weeks after submitting the expIND to the FDA. The study was also significant because it was conducted without a 14-C label on the compound, greatly reducing the time and cost to prepare dosage. Most importantly, the study provided very rapid pharmacokinetic data and enabled a critical go-forward decision by the sponsor to pursue further development of the compound. Data produced in such studies can aid study architects with dose formulation and design of subsequent clinical trials, and can also be included in the IND filing.

Covance, a pioneer of functional microdose methodology, hails the success of this study as a strong indication that microdosing has practical application in identifying promising compounds for full-scale trials. Covance's depth of knowledge in microdose studies was helpful in developing the study protocol and identifying the ideal testing panel in very short time.

"The ability to gather human PK information about drugs at sub-therapeutic, sub-toxic doses very early in the development cycle is invaluable because the additional data can provide insight into how a drug impacts human physiology before larger investment is made in other stages of development," said Dr. Jon Ruckle, Medical Director for Covance in Honolulu. "In pharmaceutical development, microdose studies are proving to be viable, important steps in the testing process - a logical outcome of the evolving 'learn and confirm' drug development paradigm."

Covance conducted its first human microdose study with a pharmaceutical compound in the U.S. in 2005 and is currently conducting microdose studies in Madison, Wisconsin as well as Honolulu, Hawaii.

About Covance
Covance, (covance.com) with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.3 billion, global operations in more than 20 countries, and more than 8,100 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website.

Statements contained in this press release, which are not historical facts, are forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All such forward-looking statements including the statements contained herein regarding anticipated trends in the Company's business are based largely on management's expectations and are subject to and qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, the Company's ability to continue to attract and retain qualified personnel, the fixed price nature of contracts or the loss of large contracts, and other factors described in the Company's filings with the Securities and Exchange Commission.

Covance and the Covance logo are registered service marks of Covance in the United States and other countries.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Covance, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Covance Completes Microdose Study Under expIND Pathway

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: Ron Lee - Covance.com 
1-800-268-2623 netpr[.]covance.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Covance, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Covance, Inc. / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

FDA Approves Genentech’s Actemra (Tocilizumab) for Giant Cell Arteritis
BTG and HealthLoop Collaborate on IO Loop™ - An Exclusive Service to Connect Patients and Interventional Oncologists throughout Treatment
BD and UniteOR Join Forces to Deliver an Integrated Tracking Solution for the Operating Room Setting
MDxHealth and Maastricht University Collaborate on Next Generation (Epi)genetic Cancer Diagnostics
BD to Invest $60 Million in Nebraska Manufacturing Facility
MDxHealth Announces New Contract with MediNcrease Health Plans Regarding ConfirmMDx and SelectMDx
Pulse Certified As A Level Four Multichannel Content Agency by Veeva
Earthly Mist - Opioid-Alternative Painkiller, Kratom Now Available in Oklahoma City
MDxHealth and Exact Sciences Sign Collaboration Agreement
BD Advances Efforts to Combat Antimicrobial Resistance with Enhanced Diagnostic Solution Offering
First European Patients Treated with DC Bead LUMI™ Radiopaque Drug-Eluting Beads
FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for Diabetic Retinopathy
Biopharmaceutical Analytical Instrumentation Market Garners Strong Opportunities from Double-digit Growth in Biosimilars Finds Frost & Sullivan
BD Completes Acquisition of Caesarea Medical Electronics
MDxHealth and Ghent University Ink Licensing and Collaboration Agreements to Develop Cancer Biomarker Visualization Technology

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit MagLar, Inc.

Visit  NAKIVO, Inc.





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)