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Xenobiotica
the fate of foreign compounds in biological systems
Volume 45, 2015 - Issue 7
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General Xenobiochemistry

Predictability of plasma concentration–time curves in humans using single-species allometric scaling of chimeric mice with humanized liver

Seigo SanohGraduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan, ;Faculty of Pharmaceutical Sciences, Hiroshima University, Hiroshima, Japan, Correspondence[email protected]
,
Yoichi NaritomiAnalysis & Pharmacokinetics Research Laboratories, Astellas Pharma Inc., Tsukuba, Japan,
,
Mami FujimotoFaculty of Pharmaceutical Sciences, Hiroshima University, Hiroshima, Japan,
,
Koya SatoGraduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan, ;Drug Metabolism Research Laboratories, Astellas Pharma Inc., Osaka, Japan,
,
Akio KawamuraDrug Metabolism Research Laboratories, Astellas Pharma Inc., Osaka, Japan,
,
Aya HoriguchiGraduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan,
,
Kazumi SugiharaFaculty of Pharmaceutical Science, Hiroshima International University, Hiroshima, Japan,
,
Yaichiro KotakeGraduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan, ;Faculty of Pharmaceutical Sciences, Hiroshima University, Hiroshima, Japan,
,
Hiroki OhshitaPXB-Mouse Production Department, PhoenixBio Co., Ltd., Hiroshima, Japan,
,
Chise TatenoR&D Department, PhoenixBio, Co., Ltd., Hiroshima, Japan, ;Liver Research Project Center, Hiroshima University, Hiroshima, Japan,
,
Toru HorieDeThree Research Laboratories, Ibaraki, Japan, and
,
Shigeyuki KitamuraNihon Pharmaceutical University, Saitama, Japan
&
Shigeru OhtaGraduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan, ;Faculty of Pharmaceutical Sciences, Hiroshima University, Hiroshima, Japan,
show all
Pages 605-614 | Received 18 Nov 2014, Accepted 09 Jan 2015, Published online: 03 Mar 2015

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Hidetaka Kamimura, Shotaro Uehara, Nao Yoneda & Hiroshi Suemizu. (2023) Empirical scaling factor for predicting human pharmacokinetic profiles of disproportionate metabolites using the Css–MRTpo method and chimeric mice with humanised livers. Xenobiotica 53:8-9, pages 523-535.
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Shun Hayashi, Hiroko Kawaguchi, Takao Watanabe, Izuru Miyawaki, Tatsuki Fukami & Miki Nakajima. (2023) Estimation of contribution of CYP2D6 to tipepidine metabolism in humans and prolongation of the half-life of tipepidine by combination use with a CYP2D6 inhibitor in chimeric mice with humanised liver. Xenobiotica 53:4, pages 241-247.
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Shogo Matsumoto, Hidetaka Kamimura, Megumi Nishiwaki, Naoki Cho, Kazuhiko Kato & Taichi Yamamoto. (2021) Empirical and theoretical approaches for the prediction of human hepatic clearance using chimeric mice with humanised liver: the use of physiologically based scaling, a novel solution for potential overprediction due to coexisting mouse metabolism. Xenobiotica 51:9, pages 983-994.
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Shogo Matsumoto, Shotaro Uehara, Hidetaka Kamimura, Hiroshi Ikeda, Satoshi Maeda, Machiko Hattori, Megumi Nishiwaki, Kazuhiko Kato & Hiroshi Yamazaki. (2021) Human total clearance values and volumes of distribution of typical human cytochrome P450 2C9/19 substrates predicted by single-species allometric scaling using pharmacokinetic data sets from common marmosets genotyped for P450 2C19. Xenobiotica 51:4, pages 479-493.
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Maki Miyamoto, Yohei Kosugi, Shinji Iwasaki, Ikumi Chisaki, Sayaka Nakagawa, Nobuyuki Amano & Hideki Hirabayashi. (2021) Characterization of plasma protein binding in two mouse models of humanized liver, PXB mouse and humanized TK-NOG mouse. Xenobiotica 51:1, pages 51-60.
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Seigo Sanoh, Yoichi Naritomi, Satoshi Kitamura, Akihiko Shinagawa, Masakazu Kakuni, Chise Tateno & Shigeru Ohta. (2020) Predictability of human pharmacokinetics of drugs that undergo hepatic organic anion transporting polypeptide (OATP)-mediated transport using single-species allometric scaling in chimeric mice with humanized liver: integration with hepatic drug metabolism. Xenobiotica 50:11, pages 1370-1379.
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Hidetaka Kamimura, Shotaro Uehara & Hiroshi Suemizu. (2020) A novel Css-MRTpo approach to simulate oral plasma concentration–time profiles of the partial glucokinase activator PF-04937319 and its disproportionate N-demethylated metabolite in humans using chimeric mice with humanized livers. Xenobiotica 50:7, pages 761-768.
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Takeshi Sawada, Yoshiyuki Yamaura, Satonori Higuchi, Haruo Imawaka & Hiroshi Yamazaki. (2020) Predicting successful/unsuccessful extrapolation for in vivo total clearance of model compounds with a variety of hepatic intrinsic metabolism and protein bindings in humans from pharmacokinetic data using chimeric mice with humanised liver. Xenobiotica 50:5, pages 526-535.
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Keigo Nakayama, Soichiro Ito, Masahiro Suzuki, Hiroaki Takubo, Hiroshi Yamazaki & Yukihiro Nomura. (2019) Prediction of human pharmacokinetics of typical compounds by a physiologically based method using chimeric mice with humanized liver. Xenobiotica 49:4, pages 404-414.
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Maki Miyamoto, Shinji Iwasaki, Ikumi Chisaki, Sayaka Nakagawa, Nobuyuki Amano & Hideki Hirabayashi. (2017) Comparison of predictability for human pharmacokinetics parameters among monkeys, rats, and chimeric mice with humanised liver. Xenobiotica 47:12, pages 1052-1063.
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Hidetaka Kamimura, Satoshi Ito, Hiroyuki Chijiwa, Takeshi Okuzono, Tomohiro Ishiguro, Yosuke Yamamoto, Sho Nishinoaki, Shin-Ichi Ninomiya, Marina Mitsui, Amit S. Kalgutkar, Hiroshi Yamazaki & Hiroshi Suemizu. (2017) Simulation of human plasma concentration–time profiles of the partial glucokinase activator PF-04937319 and its disproportionate N-demethylated metabolite using humanized chimeric mice and semi-physiological pharmacokinetic modeling. Xenobiotica 47:5, pages 382-393.
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Hidetaka Kamimura & Satoshi Ito. (2016) Assessment of chimeric mice with humanized livers in new drug development: generation of pharmacokinetics, metabolism and toxicity data for selecting the final candidate compound. Xenobiotica 46:6, pages 557-569.
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