XenoTech, LLC - Publications

Regulatory

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Guidance for Industry, Drug Interaction Studies Study Design, data Analysis and Implications for Dosing and Labeling; Draft Guidance; US Department of health and Human Services Food and Drug Administration, Denter for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), September 2006, Clinical Pharmacology. Click here for the document.
Guidance for Industry In vivo drug metabolism/drug interaction studies-study design, data analysis, and US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for industry: Drug metabolism/drug interaction studies in the drug development process: Studies in vitro: recommendations for dosing and labeling. U.S. Department of Health and Human Services, FDA, CDER, CBER, November 1998. Click here for the website.
The European Agency for the Evaluation of Medicinal Products Committee for Proprietary Medicinal Products (CPMP), Note for guidance on the investigation of drug interactions. CPMP/EWP/560/95, Click here for the website.