1. Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies

    Life Science Leader (Jun 28 2009)

    1. 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 ... (Read Full Article)

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