An open‐label study to explore the optimal design of CYP3A drug–drug interaction clinical trials in healthy Chinese people.

Autor: Chen, Jingcheng¹, Li, Jiangshuo¹, Wu, Jingxuan¹, Song, Yuqin¹, Li, Lijun¹, Zhang, Jianxiong¹, Dong, Ruihua¹ rui_hua_dong_rw@163.com

Publikováno v: Pharmacology Research & Perspectives. Aug2024, Vol. 12 Issue 4, p1-9. 9p.

Pharmacokinetics, Biotransformation, and Excretion of [ ¹⁴ C]Etelcalcetide (AMG 416) Following a Single Microtracer Intravenous Dose in Patients with Chronic Kidney Disease on Hemodialysis.

Autor: Subramanian R; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. raju.subramanian@gmail.com.; Gilead Sciences, Foster City, CA, USA. raju.subramanian@gmail.com., Zhu X; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Hock MB; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Sloey BJ; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Wu B; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Wilson SF; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Egbuna O; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Slatter JG; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Xiao J; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA., Skiles GL; Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. gskiles@amgen.com.

Publikováno v: Clinical pharmacokinetics [Clin Pharmacokinet] 2017 Feb; Vol. 56 (2), pp. 179-192.

Nonclinical Pharmacokinetics, Disposition, and Drug-Drug Interaction Potential of a Novel d-Amino Acid Peptide Agonist of the Calcium-Sensing Receptor AMG 416 (Etelcalcetide).

Autor: Subramanian R; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.) rajus@amgen.com., Zhu X; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Kerr SJ; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Esmay JD; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Louie SW; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Edson KZ; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Walter S; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Fitzsimmons M; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Wagner M; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Soto M; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Pham R; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Wilson SF; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.)., Skiles GL; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California (R.S., X.Z, S.J.K., J.D.E., S.W.L., K.Z.E, S.W., M.W., M.S., R.P., S.F.W, G.L.S); and Covance Laboratories, Madison, Wisconsin (M.F.).

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2016 Aug; Vol. 44 (8), pp. 1319-31. Date of Electronic Publication: 2016 Feb 19.

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P450-mediated O-demethylated metabolite is responsible for rat hepatobiliary toxicity of pyridyltriazine-containing PI3K inhibitors.

Autor: Subramanian R; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320 rajus@amgen.com., Aidasani D; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Bailey K; Comparative Biology and Safety Sciences, Amgen Inc., Seattle, Washington 98119 rajus@amgen.com., Branstetter D; Comparative Biology and Safety Sciences, Amgen Inc., Seattle, Washington 98119., Everds N; Comparative Biology and Safety Sciences, Amgen Inc., Seattle, Washington 98119., Jiang J; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Norman MH; Medicinal Chemistry, Amgen Inc., Thousand Oaks, California 91320., Primack R; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Skiles GL; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Soto I; Comparative Biology and Safety Sciences, Amgen Inc., Thousand Oaks, California 91320., Stec MM; Medicinal Chemistry, Amgen Inc., Thousand Oaks, California 91320., Wagner M; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Wu T; Pharmaceutics and Pre-formulation, Amgen Inc., Thousand Oaks, California 91320., Zhu X; Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, California 91320., Lebrec H; Comparative Biology and Safety Sciences, Amgen Inc., Seattle, Washington 98119.

Publikováno v: Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2014 Nov; Vol. 142 (1), pp. 298-310. Date of Electronic Publication: 2014 Aug 26.