Evaluation of Cynomolgus Monkeys for the Identification of Endogenous Biomarkers for Hepatic Transporter Inhibition and as a Translatable Model to Predict Pharmacokinetic Interactions with Statins in Humans

Author:

Chu Xiaoyan,Shih Shian-Jiun,Shaw Rachel,Hentze Hannes,Chan Grace H.,Owens Karen,Wang Shubing,Cai Xiaoxin,Newton Deborah,Castro-Perez Jose,Salituro Gino,Palamanda Jairam,Fernandis Aaron,Ng Choon Keow,Liaw Andy,Savage Mary J.,Evers Raymond

Publisher

American Society for Pharmacology & Experimental Therapeutics (ASPET)

Subject

Pharmaceutical Science,Pharmacology

Reference47 articles.

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2. Attenuation of Slc27a5 Gene Expression Followed by LC–MS Measurement of Bile Acid Reconjugation Using Metabolomics and a Stable Isotope Tracer Strategy

3. Center for Drug Evaluation and Research (CDER) (2003) Drug Approval Package: Crestor (rosuvastatin calcium) tablets, Company: Astra Zeneca Pharmaceuticals, Application No.: 021366, Approval Date: 8/13/2003, Pharmacology Review(s), Part 2, p. 29, U.S. Food and Drug Administration, Rockville, MD, http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm.

4. 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Industry: Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations [Draft Guidance], U.S. Department of Health and Human Services, Food and Drug Administration, Rockville, MD. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm292362.pdf.

5. Evaluating the In Vitro Inhibition of UGT1A1, OATP1B1, OATP1B3, MRP2, and BSEP in Predicting Drug-Induced Hyperbilirubinemia

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