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Article: Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies.
- Article from:
- Biotech Week
- Article date:
- July 8, 2009
CopyrightCOPYRIGHT 2009 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Covance Inc. 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 (see also Pharmacology).
"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, ...
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