Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies

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.

Source : news.prnewswire.com