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2. Center for Drug Evaluation and Research (CDER) (2009b) Application Number 22-363, Clinical Pharmacology and Biopharmaceutics Review(s), Part 2. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Rockville, MD. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022363s000_ClinPharmR_P2.pdf.
3. Center for Drug Evaluation and Research (CDER) (2012) Guidance for Industry: Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations [Draft Guidance], U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Rockville, MD. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf.
4. Committee for Human Medicinal Products (CHMP) (2012) Guideline on the Investigation of Drug Interactions [Final], European Medicines Agency, London. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf.
5. Genome-based analysis of the nonhuman primate Macaca fascicularis as a model for drug safety assessment