References
- Davis-Bruno KL, Atrakchi A. A regulatory perspective on issues and approaches in characterizing human metabolites. Chem Res Toxicol. 2006;19:1561–1563.
- Atrakchi A. Interpretation and considerations on the safety evaluation of human drug metabolites. Chem Res Toxicol. 2009;22:1217–1220.
- The US FDA. Guidance for industry: safety testing of drug metabolites. 2016. [Cited 2017 May 15]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079266.pdf
- ICH M3(R2). Guidance for industry: nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. 2010. [Cited 2017 May 15]. Available from: http://www.fda.gov/downloads/drugs/guidances/ucm073246.pdf
- ICH M3(R2). Questions and answers (R2) on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. 2013. [Cited 2017 May 15]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm292340.pdf2
- Anderson S, Knadler MP, Luffer-Atlas D. Overview of metabolite safety testing from an industry perspective. Bioanalysis. 2010;2:1249–1261.
- Baillie TA. Approaches to the assessment of stable and chemically reactive drug metabolites in early clinical trials. Chem Res Toxicol. 2009;22:263–266.
- Leclercq L, Cuyckens F, Mannens GSJ, et al. Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem Res Toxicol. 2009;22:280–293.
- Smith DA, Obach RS. Metabolites in safety testing (MIST): considerations of mechanisms of toxicity with dose, abundance, and duration of treatment. Chem Res Toxicol. 2009;22:267–279.
- Luffer-Atlas D. The early estimation of circulating drug metabolites in humans. Expert Opin Drug Metab Toxicol. 2012;8:985–997.
- Anderson S, Luffer-Atlas D, Knadler MP. Predicting circulating human metabolites: how good are we? Chem Res Toxicol. 2009;22:243–256.
- Loi C-M, Smith DA, Dalvie D. Which metabolites circulate? Drug Metab Dispos. 2013;41:933–951.
- Gao H, Deng S, Obach RS. A simple liquid chromatography-tandem mass spectrometry method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments. Drug Metab Dispos. 2010;38:2147–2156.
- Walker GS, Ryder TF, Sharma R, et al. Validation of isolated metabolites from drug metabolism studies as analytical standards by quantitative NMR. Drug Metab Dispos. 2011;39:433–440.
- Vishwanathan K, Babalola K, Wang J, et al. Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards. Chem Res Toxicol. 2009;22:311–322.
- Yu CP, Chen CL, Gorycki FL, et al. A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection. Rapid Commun Mass Spectrom. 2007;21:497–502.
- Yi P, Luffer-Atlas D. A radiocalibration method with pseudo internal standard to estimate circulating metabolite concentrations. Bioanalysis. 2010;2:1195–1210.
- Edarbi (azilsartan kamedoxomil) drug label. [Cited 2017 May 15]. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=52b27c75-9f5a-4816-bafd-dace9d7d2063&type=display#section-12
- Sharma R, Litchfield J, Bergman A, et al. Comparison of the circulating metabolite profile of PF-04991532, a hepatoselective glucokinase activator, across preclinical species and humans: potential implications in metabolites in safety testing assessment. Drug Metab Dispos. 2015;43:190–198.
- Gao H, Jacobs A, White RE, et al. Safety assessment of human metabolites: what’s really necessary to ascertain exposure coverage in safety tests? AAPS J. 2013;15:970–973.