--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.
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.
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|SOURCE Covance Inc.|
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