Pragmatic Approaches to Determine the Exposures of Drug Metabolites in Preclinical and Clinical Subjects in the MIST Evaluation of the Clinical Development Phase

• Published in: Chemical research in toxicology Vol. 27; no. 4; pp. 601 - 610
• Main Authors: Haglund, Johanna, Halldin, Magnus M, Brunnström, Åsa, Eklund, Göran, Kautiainen, Antti, Sandholm, Anna, Iverson, Suzanne L
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 21.04.2014
• Subjects: Animals; Area Under Curve; Clinical Trials as Topic; Cytochrome P-450 CYP2D6 - metabolism; Drug Evaluation, Preclinical; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacokinetics; United States; United States Food and Drug Administration; United States

The recent stream of regulatory guidelines on the Safety Testing of Drug Metabolites by the FDA in 2008 and the ICH in 2009 and 2012 has cast light on the importance of qualifying metabolite exposure as part of the safety evaluation of new drugs and has provided a much needed framework for the drug...