Navigation Links
Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies
Date:6/23/2009

--Integrated human AME studies comply with recent FDA guidance for earlier testing--

PRINCETON, N.J., June 23 /PRNewswire/ -- Covance Inc. today announced its integrated radiolabeled clinical pharmacology studies in compliance with Food and Drug Administration (FDA) guidance on Metabolites in Safety Testing (MIST). Recent MIST guidance requires earlier human absorption, metabolism and excretion (AME) testing in support of Investigative New Drug/Clinical Trial Application (IND/CTA) submissions.

"Integrated human AME services are designed to help reduce the time and cost of drug development by integrating clinical pharmacology AME study conduct and data management services with bioanalytical chemistry and drug metabolism," said Robert Kochan, PhD, clinical pharmacology, Covance. "Our integrated service capabilities developed by our team of experts has made us the industry leader in integrated AME testing as we recently completed our 130th AME study."

The results of AME studies provide essential information about the disposition of a drug by direct characterization of the compound's pharmacokinetics and information related to AME characteristics. Stringent data requirements for AME studies demand experienced radiochemical and chemical analysis services to obtain definitive metabolite disposition data in humans.

Covance offers 24-hour turnaround of Good Laboratory Practices (GLP) sample radioanalysis and Good Manufacturing Practices (GMP) stability and release testing of dose formulations. With more than 130 AME studies completed, Covance's team of experts deliver integrated AME study services, including on site Authorized Nuclear Pharmacist-formulated doses; cGMP formulation testing; AME study conduct and analysis of parent compound; total radioactivity; pharmacokinetic interpretation; and metabolite profiling and identification.

Covance's clinical development services include Phase I-IV clinical trial support in more than 55 countries, including emerging markets across Asia Pacific, Central and Eastern Europe, and Latin America.

About Covance

Covance, 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 $1.7 billion, global operations in more than 25 countries, and more than 9,800 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website at www.covance.com.

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.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link.

Robert Kochan

http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=89400


'/>"/>
SOURCE Covance Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. GeoVax Labs, Inc. Announces Results of 2009 Annual Shareholders Meeting
2. CoAxia, Inc. Announces $21.5M Series D Financing
3. Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs
4. Roskamp Institute Announces Enrollment of First Students to Participate in its Innovative Research Doctorate Program
5. CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer
6. ThermoGenesis Announces National Institute of Health Grant
7. ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease
8. Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections
9. Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting
10. Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes
11. Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016   Acsis , a ... that leading IT market research and advisory firm IDC ... the IDC MarketScape: Worldwide Pharmaceutical Track and Trace Software ... report provides an assessment of the capabilities and business ... trace software market. Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/28/2016)... April 28, 2016 New ... 2016" is a report that provides an overview ... R&D pipelines by identifying new targets and MOAs ... Company Profiles discussed in this H1 2016 Osteoarthritis ... Srl, AbbVie Inc., Abiogen Pharma S.p.A., Ablynx NV, ...
(Date:4/27/2016)... Avril 2016   ... +5% sur le trimestre, soutenu par une croissance ... Croissance de +16% des ventes aux hôpitaux ... Kea Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), inventeur ... aujourd,hui son chiffre d,affaires pour le premier trimestre ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... 29, 2016 , ... Spine Team Texas, a comprehensive spine physician group specializing ... their physicians has been invited to be a featured speaker at the Texas Society ... on April 30, 2016. , Dr. R. Scott McPherson, a physical medicine and ...
(Date:4/29/2016)... ... April 29, 2016 , ... World Patent Marketing ... an exercise invention which aids in proper muscle development. , "The Gym & ... Creative Director of World Patent Marketing. "Globalization has threatened the future growth of ...
(Date:4/29/2016)... ... 29, 2016 , ... Dr. Robert Mondavi, one of the dentists in ... is a fast-growing field as more patients are discovering the many different ways they ... the options currently available to them and which ones might work for their smiles. ...
(Date:4/29/2016)... ... 2016 , ... For those who skip meals occasionally (which is pretty much ... the many new lifestyle diet tips offered by nutritionists Pam Bonney and Priya Lawrence ... radio show. Bonny and Lawrence noted that because proper nutrition, including water, provides energy ...
(Date:4/29/2016)... Tampa, Fla. (PRWEB) , ... April 29, 2016 , ... ... Business Journal’s Best Places to Work employee satisfaction survey, earning them second place for ... local businesses with 25-49 employees. , “This is a great accomplishment for our ...
Breaking Medicine News(10 mins):