Microdose clinical study for drug development

Japanese Journal of Clinical Pharmacology and Therapeutics

Volumn 41, Issue 1, 2010, Pages 27-34

  Maeda, Kazuya ^a   Sugiyama, Yuichi ^a  

^a UNIVERSITY OF TOKYO   (Japan)

Author keywords

Accelerator mass spectrometer (AMS); LC MS MS; Linearity; Microdosing; Positron emission tomography (PET)

Indexed keywords

CLARITHROMYCIN; CYCLOSPORIN A; DIAZEPAM; ERYTHROMYCIN; FEXOFENADINE; MIDAZOLAM; PARACETAMOL; PHENOBARBITAL; PRAVASTATIN; PROPAFENONE; SUMATRIPTAN; VERAPAMIL; WARFARIN;

ARTICLE; CONTROLLED STUDY; DRUG MONITORING; HUMAN; IN VITRO STUDY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; POSITRON EMISSION TOMOGRAPHY;

EID: 77349103214     PISSN: 03881601     EISSN: None     Source Type: Journal    
DOI: 10.3999/jscpt.41.27     Document Type: Article

References (22)

1. Kola I and Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004 : 3 : 711-5.
2. Frank R and Hargreaves R. Clinical biomarkers in drug discovery and development. Nat Rev Drug Discov. 2003 : 2 : 566-80.
3. Grass GM and Sinko PJ. Physiologically-based pharmacokinetic simulation modelling. Adv Drug Deliv Rev. 2002 : 54 : 433-51.
4. Chiba M, Ishii Y and Sugiyama Y. Prediction of hepatic clearance in human from in vitro data for successful drug development. Aaps J. 2009 : 11 : 262-76.
5. Maeda K and Sugiyama Y. In vitro-in vivo scale-up of drug transport activities. You G and Morris ME (Eds). Drug transporters. New Jersey : John Wiley & Sons, Inc., 2007 : 557-88.
6. Japanese source
7. Lappin G, Kuhnz W, Jochemsen R, Kneer J, Chaudhary A, Oosterhuis B, et al. Use of microdosing to predict pharmacokinetics at the therapeutic dose : experience with 5 drugs. Clin Pharmacol Ther. 2006 : 80 : 203-15.
8. EUMAPP. Outcomes from EUMAPP-A study comparing in vitro, in silico, microdose and pharmacological dose pharmacokinetics. http://www. eumapp.com/pdfs/EUMAPP%20SUMMARY.pdf
9. Yamane N, Tozuka Z, Sugiyama Y, Tanimoto T, Yamazaki A and Kumagai Y. Microdose clinical trial : quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 : 858 : 118-28.
10. Japanese source
11. Iwatsubo T, Suzuki H and Sugiyama Y. Prediction of species differences (rats, dogs, humans) in the in vivo metabolic clearance of YM796 by the liver from in vitro data. J Pharmacol Exp Ther. 1997 : 283 : 462-9.
12. Watanabe T, Kusuhara H, Maeda K, Shitara Y and Sugiyama Y. Physiologically based pharmacokinetic modeling to predict transporter-mediated clearance and distribution of pravastatin in humans. J Pharmacol Exp Ther. 2009 : 328 : 652-62.
13. Food and Drug Administration (FDA), Guidance for Industry, Safety testing of drug metabolites. 2008.2
14. Japanese source
15. Japanese source
16. Lee YJ, Maeda J, Kusuhara E Okauchi T, Inaji M, Nagai Y, et al. In vivo evaluation of P-glycoprotein function at the blood-brain barrier in nonhuman primates using [11C] verapamiL J Pharmacol Exp Ther. 2006 : 316 : 647-53.
17. Takano A, Kusuhara H, Suhara T, Ieiri I, Morimoto T, Lee YJ, et al. Evaluation of in vivo P-glycoprotein function at the blood-brain barrier among MDRl gene polymorphisms by using 11C-verapamil. J Nucl Med. 2006 : 47 : 1427-33.
18. Sasongko L, Link JM, Muzi M, Mankoff DA, Yang X, Collier AC, et al. Imaging P-glycoprotein transport activity at the human blood-brain barrier with positron emission tomography. Clin Pharmacol Ther. 2005 : 77 : 503-14.
19. Japanese source
20. Madan A, O'Brien Z, Wen J, O'Brien C, Farber RH, Beaton G, et al. A pharmacokinetic evaluation of five H (1) antagonists after an oral and intravenous microdose to human subjects. Br J Clin Pharmacol. 2009 : 67 : 288-98.
21. Zhou XJ, Garner RC, Nicholson S, Kissling CJ and Mayers D. Microdose pharmacokinetics of IDX899 and IDX989, candidate HIV-1 non-nucleoside reverse transcriptase inhibitors, following oral and intravenous administration in healthy male subjects. J Clin Pharmacol. 2009 : 49 : 1408-16.
22. Japanese source