• Search Research Projects
  • Search Researchers
  • How to Use
  1. Back to previous page

Design and Data Analysis for clinical pharmacokinetic trials to Evaluate Mechanisms for the Pharmacokinetic Variability

Research Project

Project/Area Number 19590139
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Medical pharmacy
Research InstitutionUniversity of Toyama

Principal Investigator

HASHIMOTO Yukiya  University of Toyama, 大学院・医学薬学研究部(薬学), 教授 (90228429)

Co-Investigator(Kenkyū-buntansha) TAGUCHI Masato  富山大学, 大学院・院医学薬学研究部(薬学), 講師 (20324056)
NOZAWA Takashi  富山大学, 大学院・院医学薬学研究部(薬学), 准教授 (00180737)
FUJIKI Akira  富山大学, 大学病院, 講師 (90181338)
YUICHIRO Kayano  富山大学, 大学院・院医学薬学研究部(薬学), 助教 (80452093)
Project Period (FY) 2007 – 2008
Project Status Completed (Fiscal Year 2008)
Budget Amount *help
¥4,420,000 (Direct Cost: ¥3,400,000、Indirect Cost: ¥1,020,000)
Fiscal Year 2008: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Fiscal Year 2007: ¥2,340,000 (Direct Cost: ¥1,800,000、Indirect Cost: ¥540,000)
Keywords薬物動態学 / 2点採血デザイン / 経口クリアランス / 臨床薬物動態試験 / カルベジロール / 心不全 / 薬物動態 / 臨床試験 / 個別投与設計 / 採血デザイン / ピーク・トラフ
Research Abstract

医薬品を適正に使用するためには、薬物動態特性と個体間変動機構を明らかにし、患者個々に投与設計を行う事が必要である。しかし、一人の患者から速度論的解析に耐えるほど数多くの血中薬物濃度データを得ることは多くの場合困難であることに加え、市販後に一施設で行う臨床薬物動態試験では、対象患者が多くても数十人に限られるため、従来の薬物速度論的解析法は適用が困難である。本研究では、症例数および採血点数が少ない探索的な臨床試験データの解析法として、最近申請者らが考案した三段階の解析法が有用であることを検証するとともに、臨床試験のデザインとデータ解析の発展を目指した。

Report

(3 results)
  • 2008 Annual Research Report   Final Research Report ( PDF )
  • 2007 Annual Research Report
  • Research Products

    (42 results)

All 2008 2007

All Journal Article (19 results) (of which Peer Reviewed: 19 results) Presentation (23 results)

  • [Journal Article] Contribution of Na(^+)-independent nucleoside transport to ribavirin uptake in the rat intestine and human epithelial LS180 cells2008

    • Author(s)
      Takaai M., Morishita H, Ishida K, Taguchi M, and Hashimoto Y.
    • Journal Title

      Eur. J. Pharmacol 601

      Pages: 61-65

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Stereoselective oxidation and glucuronidation of carvedilol in human liver and intestinal microsomes2008

    • Author(s)
      Ishida K., Taira S., Morishita H., Kayano Y, Taguchi M, and Hashimoto Y
    • Journal Title

      Biol. Pharm. Bull 31

      Pages: 1297-1300

    • NAID

      110006684359

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] The apical uptake transporter of levofloxacin is distinct from the peptide transporter in human intestinal epithelial Caco-2 cells2008

    • Author(s)
      Fukumori S, Murata T, Takaai M, Tahara K, Taguchi M., and Hashimoto Y
    • Journal Title

      Drug Metab. Pharmacokinet 23

      Pages: 373-378

    • NAID

      10024384721

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Directional transcellular transport of bisoprolol in P-glycoprotein expressed LLC-GA5-COL150 cells, but not in renal epithelial LLC PK_1 Cells2008

    • Author(s)
      Tahara K., Kagawa Y, Takaai M, Taguchi M., and Hashimoto Y.
    • Journal Title

      Drug Metab. Pharmacokinet 23

      Pages: 340-346

    • NAID

      10024384607

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetics of R-and S-carvedilol in routinely treated Japanese patients with heart failure2008

    • Author(s)
      Horiuchi I., Nozawa T, Fujii N., Inoue H., Honda M, Shimizu T, Taguchi M, and Hashimoto Y.
    • Journal Title

      Biol. Pharm. Bull 23

      Pages: 976-980

    • NAID

      110006663963

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Additional notes on clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance2008

    • Author(s)
      Takaai M, Kayano Y, Shimizu T, Taguchi M., and Hashimoto Y.
    • Journal Title

      Drug Metab. Pharmacokinet 23

      Pages: 128-133

    • NAID

      10024188052

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Additional notes on clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance.2008

    • Author(s)
      Takaai, Mari
    • Journal Title

      Drug Metab. Pharmacokinet. 23

      Pages: 128-133

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetics of R- and S-carvedilol in routinely treated Japanese patients with heart failure.2008

    • Author(s)
      Horiuchi, Isao
    • Journal Title

      Biol. Pharm. Bull. 31

      Pages: 976-980

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Stereoselective oxidation and glucuronidation of carvedilol in human liver and intestinal microsomes.2008

    • Author(s)
      Ishida, Kazuya
    • Journal Title

      Biol. Pharm. Bull. 31

      Pages: 1297-1300

    • Related Report
      2008 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Population pharmacokinetics and proton pump inhibitory effects of intravenous lansoprazole in healthy Japanese males2007

    • Author(s)
      Sakurai Y, Hirayama M, Hashimoto M, Tanaka T, Hasegawa S, Irie S, Ashida K, Kayano Y, Taguchi M., and Hashimoto Y.
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2238-2243

    • NAID

      110006546418

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetic analysis of transcellular transport of levofloxacin across LLC-PK1 and Caco-2 cell monolayers2007

    • Author(s)
      Takaai M, Suzuki H, Ishida K, Tahara K, and Hashimoto Y.
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2167-2172

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Simulation for clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance2007

    • Author(s)
      Ishida K, Kayano Y, Taguchi M., and Hashimoto
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2159-2162

    • NAID

      110006473499

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] UGT2B7*3 did not affect the pharmacokinetics of R-and S carvedilol in healthy Japanese2007

    • Author(s)
      Honda M, oyoda W, Shimizu T, Horiuchi I., Kayano Y, Taguchi M., Nozawa T, Inoue H, and Hashimoto Y.
    • Journal Title

      Drug Metab. Pharmacokinet 22

      Pages: 382-386

    • NAID

      10019806805

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Nonlinear mixed effects model analysis of the pharmacokinetics of aripiprazole in healthy Japanese males2007

    • Author(s)
      Koue T, Kubo M, Funaki T, Fukuda T., Azuma J, Takaai M., Kayano Y, and Hashimoto Y
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2154-2158

    • NAID

      110006473498

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Rapid and drastic induction of CYP3A4 mRNA expression via vitamin D receptor in human intestinal LS180 cells2007

    • Author(s)
      Fukumori S, Murata T, Taguchi M, and Hashimoto Y
    • Journal Title

      Drug Metab. Pharmacokinet 22

      Pages: 377-381

    • NAID

      10019806790

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Stereoselective metabolism of carvedilol by the beta naphthoflavone-inducible enzyme in human intestinal epithelial Caco-2 cells2007

    • Author(s)
      Ishida K, Honda M., Shimizu T, Taguchi M, and Hashimoto Y.
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 1930-1933

    • Related Report
      2008 Final Research Report
    • Peer Reviewed
  • [Journal Article] Nonlinear mixed effects model analysis of the pharmacokinetics of aripiprazole in healthy Japanese males2007

    • Author(s)
      Koue, Toshiko
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2154-2158

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Simulation for clinical repeated-dose pharmacokinetic trials applying apeak-and-trough sampling design to estimate oral clearance2007

    • Author(s)
      Ishida, Kazuya
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2159-2162

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Population pharmacokinetics and proton pump inhibitory effects of intravenous lansoprazole in healthy Japanese males2007

    • Author(s)
      Sakurai, Yuichi
    • Journal Title

      Biol. Pharm. Bull 30

      Pages: 2238-2243

    • Related Report
      2007 Annual Research Report
    • Peer Reviewed
  • [Presentation] 胆管結紮ラットを用いたボセンタンの肝クリアランス変動機構解析2008

    • Author(s)
      森ゆんい, 掘内威佐男, 田口雅登, 市田蕗子, 橋本征也
    • Organizer
      日本薬学会北陸支部第119回例会
    • Place of Presentation
      金沢
    • Year and Date
      2008-11-08
    • Related Report
      2008 Final Research Report
  • [Presentation] リバビリンの小腸吸収に対するNa^+非依存性トランスポーターの関与2008

    • Author(s)
      鷹合麻里, 森下宙輝, 四谷綾乃, 鈴木寿樹, 田口雅登, 橋本征也
    • Organizer
      日本薬剤学会第23年会
    • Place of Presentation
      札幌
    • Year and Date
      2008-05-20
    • Related Report
      2008 Final Research Report
  • [Presentation] ピーク・トラフ2点採血デザインに基づくボセンタンの体内動態解析2008

    • Author(s)
      田口雅登, 森ゆんい, 堀内威佐男, 橋本征也, 伊吹圭二郎, 廣野恵一, 上勢敬一郎, 市田蕗子, 芳村直樹, 北岡千佳, 中村常之, 高月晋一, 中山智孝, 佐地勉
    • Organizer
      第14回日本小児肺循環研究会
    • Place of Presentation
      東京
    • Year and Date
      2008-02-02
    • Related Report
      2008 Final Research Report
  • [Presentation] Simulation for clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance2008

    • Author(s)
      Kayano Y, Takaai M, Ishida K, Taguchi M., and Hashimoto Y.
    • Organizer
      2008 AAPS Annual Meeting and Exposition
    • Place of Presentation
      Atlanta
    • Related Report
      2008 Final Research Report
  • [Presentation] Stereoselective oxidation and glucuronidation of carvedilol in human liver and intestinal microsomes2008

    • Author(s)
      Ishida K, Morishita H., Kayano Y, Taguchi M., and Hashimoto Y
    • Organizer
      AAPS Annual Meeting and Exposition
    • Place of Presentation
      Atlanta
    • Related Report
      2008 Final Research Report
  • [Presentation] The peptide transporter is not responsible for uptake of levofloxacin in human intestinal Caco-2 cells2008

    • Author(s)
      Fukumori S, Murata T, Takaai M, Tahara K, Taguchi M, and Hashimoto Y
    • Organizer
      Pan-Pacific International Partnership Conference on Pharmaceutical and Life Sciences
    • Place of Presentation
      Nagoya
    • Related Report
      2008 Final Research Report
  • [Presentation] Stereoselective glucuronidation and oxidation of carvedilol in human liver and intestinal microsomes2008

    • Author(s)
      Ishida K, Taira S, Morishita H, Taguchi M, and Hashimoto Y
    • Organizer
      Pan-Pacific International Partnership Conference on Pharmaceutical and Life Sciences (The 4th US-Japan Joint Conference)
    • Place of Presentation
      Nagoya
    • Related Report
      2008 Final Research Report
  • [Presentation] 胆管結紮ラットを用いたボセンタンの体内動態変動機構解析2008

    • Author(s)
      森ゆんい, 掘内威佐男, 田口雅登, 市田蕗子, 橋本征也
    • Organizer
      第29回日本臨床薬理学会年会
    • Place of Presentation
      東京
    • Related Report
      2008 Final Research Report
  • [Presentation] Pharmacokinetics of bosentan in rats with bile duct ligation-induced liver dysfunction2008

    • Author(s)
      Horiuchi I., Mori Y, Taguchi M, Ichida F, and Hashimoto Y.
    • Organizer
      第23回日本薬物動態学会年会
    • Place of Presentation
      熊本
    • Related Report
      2008 Final Research Report
  • [Presentation] Characterization of levofloxacin transport in human intestinal LS180 cells2008

    • Author(s)
      Fukumori S, Masago M., Ishida K, Kayano Y, Taguchi M, and Hashimoto Y.
    • Organizer
      第23回日本薬物動態学会年会
    • Place of Presentation
      熊本
    • Related Report
      2008 Final Research Report
  • [Presentation] ピーク・トラフ2点採血による連投薬物動態試験のシミュレーション評価2008

    • Author(s)
      萱野勇一郎, 鷹合麻里, 石田和也, 田口雅登, 橋本征也
    • Organizer
      日本薬学会第128年会
    • Place of Presentation
      横浜
    • Related Report
      2008 Final Research Report
  • [Presentation] Simulation for clinical repeated-dose pharmacokinetic trials applying a peak-and-trough sampling design to estimate oral clearance.2008

    • Author(s)
      Kayano, Yuichiro
    • Organizer
      2008 AAPS Annual Meeting and Exposition
    • Place of Presentation
      Atlanta
    • Related Report
      2008 Annual Research Report
  • [Presentation] ピーク・トラフ2点採血による連投薬物動態試験の精能評価2007

    • Author(s)
      橋本 征也
    • Organizer
      第28回日本臨床薬理学会年会
    • Place of Presentation
      宇都宮
    • Year and Date
      2007-11-28
    • Related Report
      2007 Annual Research Report
  • [Presentation] Caco-2細胞におけるレボフロキサシン輸送の速度論的評価と特性解析2007

    • Author(s)
      鈴木寿樹, 鷹合麻里, 石田和也, 田原克寿, 橋本征也
    • Organizer
      日本薬学会北陸支部第117回例会
    • Place of Presentation
      金沢
    • Year and Date
      2007-11-11
    • Related Report
      2008 Final Research Report
  • [Presentation] 心不全時におけるカルベジロール体内動態の変動性評価2007

    • Author(s)
      堀内威佐男, 本多睦子, 清水貴子, 萱野勇一郎, 田口雅登, 能澤孝, 井上博, 橋本征也
    • Organizer
      日本薬学会北陸支部第117回例会
    • Place of Presentation
      金沢
    • Year and Date
      2007-11-11
    • Related Report
      2008 Final Research Report
  • [Presentation] ラットおよび培養ヒト腸上皮細胞を用いたリバビリンの小腸吸収特性解析2007

    • Author(s)
      森下宙輝, 鷹合麻里, 四谷綾乃, 鈴木寿樹, 石田和也, 田口雅登, 橋本征也
    • Organizer
      日本薬学会北陸支部第118回例会.
    • Place of Presentation
      富山
    • Year and Date
      2007-07-05
    • Related Report
      2008 Final Research Report
  • [Presentation] Stereoselective metabolism of carvedilol by the beta-naphthoflavone-inducible enzyme in human intestinal epithelial Caco-2 cells2007

    • Author(s)
      Ishida K, Honda M, Shimizu T, Taguchi M, and Hashimoto Y.
    • Organizer
      The 8th International ISSX Meeting
    • Place of Presentation
      Sendai
    • Related Report
      2008 Final Research Report
  • [Presentation] Pharmacokinetic analysis of transcellular transport of levofloxacin across LLC-PK1 and Caco-2 cell monolayers2007

    • Author(s)
      Takaai M, Suzuki H, Ishida K, Tahara K, and Hashimoto Y.
    • Organizer
      The 8th International ISSX Meeting
    • Place of Presentation
      Sendai
    • Related Report
      2008 Final Research Report
  • [Presentation] Contribution of basolateral and apical transporters to directional transcellular transport of cationic drugs in porcine kidney LLC-PK1 cell monolayers2007

    • Author(s)
      Tahara K, Kagawa Y, Saigusa K, Takaai M, Taguchi M, and Hashimoto Y
    • Organizer
      The 8th International ISSX Meeting
    • Place of Presentation
      Sendai
    • Related Report
      2008 Final Research Report
  • [Presentation] 日本人健常者におけるアリピプラゾール体内動態の母集団解析2007

    • Author(s)
      鷹合麻里, 小上淑子, 久保正則, 船木朋雄, 福田剛史, 東純一, 萱野勇一郎, 橋本征也
    • Organizer
      日本臨床薬理学会第28年会
    • Place of Presentation
      宇都宮
    • Related Report
      2008 Final Research Report
  • [Presentation] ピーク・トラフ2点採血による連投薬物動態試験の精能評価2007

    • Author(s)
      橋本征也, 石田和也, 萱野勇一郎, 田口雅登
    • Organizer
      日本臨床薬理学会第28年会
    • Place of Presentation
      宇都宮
    • Related Report
      2008 Final Research Report
  • [Presentation] LLC-PK1細胞を用いたカチオン性薬物の尿細管分泌機構の速度論的解析2007

    • Author(s)
      加川由佳, 田原克寿, 三枝克也, 鷹合麻里, 田口雅登, 橋本征也
    • Organizer
      日本医療薬学会第17年会
    • Place of Presentation
      前橋
    • Related Report
      2008 Final Research Report
  • [Presentation] 日本人健常者のカルベジロール体内動態に及ぼすUGT2B7*3の影響2007

    • Author(s)
      田口雅登, 本多睦子, 豊田若子, 堀内威佐男, 清水貴子, 萱野勇一郎, 橋本征也, 能澤孝, 井上博
    • Organizer
      日本医療薬学会第17年会
    • Place of Presentation
      前橋
    • Related Report
      2008 Final Research Report

URL: 

Published: 2007-04-01   Modified: 2016-04-21  

Information User Guide FAQ News Terms of Use Attribution of KAKENHI

Powered by NII kakenhi