教員紹介

千葉 康司
Koji Chiba

所属・肩書

臨床薬学科/臨床薬理学研究室、 薬科学科/臨床解析学研究室(教授)

SDGsへの取り組み

最終学歴

東京薬科大学大学院薬学研究科修士課程修了

取得学位

博士(医学)

所属学会

薬物動態学会、薬剤学会、臨床薬理学会、薬学会、HAB研究機構、医薬品開発支援機構

現在の専門分野

臨床薬理(モデリング・シミュレーション)

現在の研究課題

薬物PK/PDの個体間変動の予測

主要研究業績

1.欧米人を対象に構築された薬物動態・薬効モデルの日本人への適用性評価

2.メタアナリシス薬効モデルによる民族差の検討

3.グローバル開発時の日本人第I相試験の意義に関する研究

最近の研究業績

1.Ho H, Zhang S, Kurosawa K, Chiba K. In silico modeling for ex vivo placental transfer of morphine. J Clin Pharmacol., 2022; 62 (Suppl 1), 140-146.

2.Yoshikado T, Aoki Y, Mochizuki T, Rodrigues AD, Chiba K, Kusuhara H, Sugiyama Y. Cluster Gauss-Newton method analyses of PBPK model parameter combinations of coproporphyrin-I based on OATP1B-mediated rifampicin interaction studies. CPT Pharmacometrics Syst Pharmacol., 2022; 11(10), 1341-1357.

3.Kurosawa K, Noguchi S, Nishimura T, Tomi M, Chiba K*. Transplacental Pharmacokinetic Model of Digoxin Based on Ex Vivo Human Placental Perfusion Study. Drug Metab Dispos. 2022; 50(3):287-298.

4.Kurosawa K, Chiba K*, Noguchi S, Nishimura T, Tomi M. Development of a Pharmacokinetic model of transplacental transfer of metformin to predict in vivo fetal exposure. Drug Metab Dispos. 2020; 48(12):1293-1302

5.Sarashina, A., Chiba, K., Tatami, S., Kato, Y. Physiologically based pharmacokinetic model of the DPP-4 inhibitor linagliptin to describe its nonlinear pharmacokinetics in humans. J Pharm. Sci. 2020; 09(7):2336

6.Shibata S, Maiko Matsushita M, Tsukamoto K, Chiba K, Ozaki K, Suzuki T. A study on the description of anticancer drug combination therapy in the package insert in Japan. BPB Reports. 2020; 3(5): 157-165.

7.Oishi M, Takano Y, Torita Y, Malhotra B, Chiba K*. Physiological based pharmacokinetic modeling to estimate in vivo Ki of ketoconazole on renal P-gp using human drug-drug interaction study result of fesoterodine and ketoconazole. Drug Metab Pharmacokinet. 2018; 33(1):90-95.

8.Yoshikado T, Toshimoto K, Maeda K, Kusuhara H, Kimoto E, Rodrigues AD, Chiba K, Sugiyama Y. PBPK Modeling of Coproporphyrin I as an Endogenous Biomarker for Drug Interactions Involving Inhibition of Hepatic OATP1B1 and OATP1B3. CPT Pharmacometrics Syst Pharmacol. 2018; 7(11):739-747.

9.Haraya K, Kato M, Chiba K, Sugiyama Y.Prediction of inter-individual variability on the pharmacokinetics of CYP2C8 substrates in human. Drug Metab Pharmacokinet. 2017; 32(6):277-285.

10.Terada K, Matsushima Y, Matsunaga K, Takata J, Karube Y, Ishige A, Chiba K. The Kampo medicine Yokukansan (YKS) enhances nerve growth factor (NGF)-induced neurite outgrowth in PC12 cells. Bosn J Basic Med Sci. 2017; 18(3):224-233.

11.Yahata M, Chiba K, Watanabe T, Sugiyama Y. Possibility of Predicting Serotonin Transporter Occupancy From the In Vitro Inhibition Constant for Serotonin Transporter, the Clinically Relevant Plasma Concentration of Unbound Drugs, and Their Profiles for Substrates of Transporters. J Pharm Sci. 2017;106(9):2345-2356.

12.Toshimoto K, Tomoda Y, Chiba K, Sugiyama Y. Analysis of the Change in the Blood Concentration-Time Profile Caused by Complex Drug-Drug Interactions in the Liver Considering the Enterohepatic Circulation: Examining Whether the Inhibition Constants for Uptake, Metabolism, and Biliary Excretion Can be Recovered by the Analyses Using Physiologically Based Pharmacokinetic Modeling. J Pharm Sci. 2017;106(9):2727-2738.

13.Chiba K*, Shimizu K, Kato M, Miyazaki T, Nishibayashi T, Terada K, Sugiyama Y. Estimation of Interindividual Variability of Pharmacokinetics of CYP2C9 Substrates in Humans. J Pharm Sci. 2017;106(9):2695-2703.

14.Shibata S, Wayama Y, Tsuyuki A, Matsushita M, Chiba K, Matsuki E, Okamoto S, Suzuki T. An Empirical Study of the Prescription Pattern of Drugs for Hematological Malignancies in Japan from 2010-2014. Biol Pharm Bull. 2017; 40(6):894-901.

15.Shirotani S, Chiba K. Effective use of foreign clinical data in approvals for medical devices in Japan. J Regul Sci 2017; 5(1),35-40.

16.Oka M, Nakazawa Y, Hada N, Kiuchi F, Matsushima Y, Chiba K, Takehana, M. Evaluation of the inhibitory effects of Rokumigan and Hachimijiogan on cataract formation in a rat model of streptozotocin-induced type-1 diabetes. Jpn J Society Cataract Res. 2016; 28,97-105.

17.Shibata S, Uemura R, Chiba K, Suzukia T. A Comprehensive analysis of factors that contribute to conditional approval and all-case surveillance designations that subsequently lead to shortening of review times in Japan. J Regul Sci. 2016; 4(1),1-9

18.Haraya K, Kato M, Chiba K, Sugiyama Y. Prediction of variability on the pharmacokinetics of CYP1A2 substrates in non-smoking healthy volunteers. Drug Metab Pharmacokinet. 2016; 31(4), 276-284.

19.Yamazaki H, Kunikane E, Nishiyama S, Murayama N, Shimizu M, Sugiyama Y, Chiba K, Ikeda T. Human plasma concentrations of tolbutamide and acetaminophen extrapolated from in vivo animal pharmacokinetics using in vitro human hepatic clearances and simple physiologically based pharmacokinetics modeling for radio-labeled microdose clinical studies. Radioisotopes. 2015; 64(8), 509-519.

20.Narita Y, Matsushima Y, Shiroiwa T, Chiba K, Nakanishi Y, Kurokawa T, Urushihara H. Cost-effectiveness analysis of EGFR mutation testing and gefitinib as first-line therapy for non-small cell lung cancer. Lung Cancer. 2015; 90(1), 71-77. 2015.

21.Nakajima K, Dagher R, Strawn L, Urushidani1 J, Kurokawa T, Chiba K. The relationship between development start lag and approval lag in oncology drug development in Japan. Ther.Innov.Regul.Sci. 2015; 1-9.

22.Chiba K*, Shimizu K, Kato M, Nishibayashi T, Terada K, Izumo N, Sugiyama Y. Prediction of inter-individual variability in pharmacokinetics of CYP2C19 substrates in humans. Drug Metab Pharmacokinet. 2014; 29(5), 379-386.

23.Chiba K, Yoshitsugu H, Kyosaka Y, Iida S, Yoneyama K, Tanigawa T, Fukushima T, Hiraoka M. A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase I studies still needed? J Clin Pharmacol. 2014; 54(5), 483-494.

24.Terada K, Kojima Y, Watanabe T, Izumo N, Chiba K*, Karube Y. Inhibition of nerve growth factor-induced neurite outgrowth from PC12 cells by dexamethasone: signaling pathways through the glucocorticoid receptor and phosphorylated Akt and ERK1/2. PLoS One. 2014; 9(3):e93223.

25.Terada K, Izumo N, Suzuki B, Karube Y, Morikawa T, Ishibashi Y, Kameyama T, Chiba K, Sasaki N, Iwata K, Matsuzaki H, Manabe T. Fluvoxamine moderates reduced voluntary activity following chronic dexamethasone infusion in mice via recovery of BDNF signal cascades. Neurochem Int. 2014; 69:9-13.

26.Shirotani M, Kurokawa T, Chiba K*. Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan. J Clin Pharmacol. 2014; 54(7)753-764.

27.Shirotani M, Suwa T, Kurokawa T, Chiiba K*. Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials. J. Clin. Pharmacol. 2013; 54(4)438-445.

28.Abe S, Chiba K, Suwa T. Low-molecular-weight heparin pharmacokinetics: A dual absorption model approach. Int. J. Clin. Pharmacol. Ther. 2013; 51(6):482-9.

29.Nakajima K, Chiba K, Tsubamoto H, Walsh J, Strawn L, Suwa T. Potential factors correlating to the PMDA's decision to waive Japanese Phase 2 and 3 studies for oncology drugs New Drug Application in Japan. Invest. New Drugs. 2013; 31(4):1051-5.

30.Oishi M, Chiba K, Fukushina T, Tomono Y, Suwa T. Different truncation methods of AUC between Japan and the EU for bioequivalence assessment: Influence on the regulatory judgment. Drug Metab. Pharmacokinet. 2012; 27(6):658-662.

31.Chiba K, Kato M, Ito T, Suwa T, Sugiyama Y. Inter-individual variability of in vivo CYP2D6 activity in different genotypes. Drug Metab. Pharmacokinet. 2012; 27(4):405-413.

32.Muto C, Dai H, Teeter G, Johnson S, Cropp B, Chiba K, Suwa T. The pharmacokinetics and pharmacodynamics of PF-00734200, a DPP-IV inhibitor, in healthy Japanese subjects. In. J. Clin. Pharmacol. Ther. 2012; 50(7):505-509.

33.Oishi M, Chiba K, Malhotra B, Suwa T. Pharmacokinetics of tolterodine in Japanese and Koreans: physiological and stochastic assessment of ethnic differences. Drug Metab. Pharmacokinet. 2011; 26(3):236-241.

34.Muto C, Chiba K, Suwa T. A population pharmacokinetic and pharmacodynamic modeling of pegvisomant in Asian and Western acromegaly patients. J. Clin. Pharmacol. 2011; 51(12):1628-1643.

35.Muto C, Liu P, Chiba K, Suwa T. Pharmacokinetic-pharmacodynamic analysis of azithromycin extended release in Japanese patients with common respiratory tract infectious disease. J. Antimicrob. Chemother. 2011; 66(1):165-174.

36.Mori Y, Chiba K, Takahashi H, Ogata H. A population approach to eplerenone pharmacokinetics and saturable protein binding. Drug Metab. Pharmacokinet. 2011; 25(6):551-559.

37.Kato M, Chiba K, Ito K, Koue T, Sugiyama Y. Prediction of interindividual variability in pharmacokinetics for CYP3A4 substrates in humans. Drug Metab. Pharmacokinet. 2010; 25(4):367-378.

38.Kusama M, Toshimoto K, Maeda K, Hirai Y, Imai S, Chiba K, Akiyama Y, Sugiyama Y. In silico classification of major clearance pathways of drugs with their physiochemical parameters. Drug Metab. Dispos. 2010; 38(8):1362-1370.

39.Ito T, Kato M, Chiba K, Okazaki O, Sugiyama Y. Estimation of the interindividual variability of cytochrome 2D6 activity from urinary metabolic ratios in the literature. Drug Metab. Pharmacokinet. 2010; 25(3):243-253.

40.Oishi M, Chiba K, Malhotra B, Suwa T. Effect of the CYP2D6*10 genotype on tolterodine pharmacokinetics. Drug Metab. Dispos. 2010; 38(9):1456-1463.

41.Abe S, Chiba K, Cirincione B, Grasela TH, Ito K, Suwa T. Population pharmacokinetic analysis of linezolid in patients with infectious disease: Application to lower body weight and elderly patients. J. Clin. Pharmacol. 2009; 49(9):1071-1078.

42.Kusama M, Maeda K, Chiba K, Aoyama A, Sugiyama Y. Prediction of the effects of genetic polymorphism on the pharmacokinetics of CYP2C9 substrates from in vitro data. Pharm. Res. 2009; 26(4):822-835.

著書及び総説

1.千葉康司 他. 基礎からの薬物動態学,8 薬物相互作用,テコム,(2020) 109-121

2.千葉康司 他. 個別化医療を目指した臨床薬物動態学,3.4.1小児等患者の薬物動態,廣川書店,(2016) 120-132

3.千葉康司 他. 新しい薬学事典,D薬事法規等,(独)医薬品医療機器総合機構法,朝倉書店,(2012) 425-428

4.千葉康司 他. 薬物動態試験実践資料集, 3.1臨床薬物動態試験の概要, 情報機構, (2009) 391-404

5.千葉康司 他. 創薬 20の事例に見るその科学と研究開発戦略, 1.3 開発研究, 丸善株式会社, (2008) 7-14

入試情報 ADMISSION