Utilizing drug-drug interaction prediction tools during drug development: Enhanced decision making based on clinical risk

Drug Metabolism and Disposition

Volumn 39, Issue 11, 2011, Pages 2076-2084

  Shardlow, Carole E ^a   Generaux, Grant T ^b   MacLauchlin, Christopher C ^b   Pons, Nicoletta ^c   Skordos, Konstantine W ^b   Bloomer, Jackie C ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

^b GLAXOSMITHKLINE   (United States)

^c Aptuit Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ATORVASTATIN; BUFURALOL; CAFFEINE; CASOPITANT; CERIVASTATIN; CYTOCHROME P450 3A4; DESIPRAMINE; DEXTROMETHORPHAN; DICLOFENAC; FLURBIPROFEN; MEPHENYTOIN; MIDAZOLAM; NIFEDIPINE; PACLITAXEL; PHENACETIN; SIMVASTATIN; THEOPHYLLINE; TRIAZOLAM; WARFARIN;

ARTICLE; CLINICAL DECISION MAKING; CLINICAL RISK; CONTROLLED STUDY; DRUG DEVELOPMENT; DRUG INTERACTION; DRUG LIVER LEVEL; DRUG METABOLISM; ENZYME ACTIVE SITE; ENZYME INHIBITION; ENZYME SUBSTRATE; HUMAN; HUMAN CELL; IN VITRO STUDY; INTESTINE FUNCTION; MAXIMUM PLASMA CONCENTRATION; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK; RISK ASSESSMENT;

CYTOCHROME P-450 ENZYME SYSTEM; DECISION MAKING, COMPUTER-ASSISTED; DRUG DISCOVERY; DRUG INTERACTIONS; ENZYME INHIBITORS; EVALUATION STUDIES AS TOPIC; LIVER; MODELS, CHEMICAL; RETROSPECTIVE STUDIES; RISK ASSESSMENT;

EID: 80054734196     PISSN: 00909556     EISSN: 1521009X     Source Type: Journal    
DOI: 10.1124/dmd.111.039214     Document Type: Article

References (34)

1. Borges S, Li L, Hamman MA, Jones DR, Hall SD, and Gorski JC (2005) Dextromethorphan to dextrorphan urinary metabolic ratio does not reflect dextromethorphan oral clearance. Drug Metab Dispos 33:1052-1055. (Pubitemid 41002788)
2. Brown HS, Galetin A, Hallifax D, and Houston JB (2006) Prediction of in vivo drug-drug interactions from in vitro data: factors affecting prototypic drug-drug interactions involving CYP2C9, CYP2D6 and CYP3A4. Clin Pharmacokinet 45:1035-1050. (Pubitemid 44436005)
3. Chen M, Nafziger AN, and Bertino JS Jr (2006) Drug-metabolizing enzyme inhibition by ketoconazole does not reduce interindividual variability of CYP3A activity as measured by oral midazolam. Drug Metab Dispos 34:2079-2082. (Pubitemid 44837769)
4. Cheng Y and Prusoff WH (1973) Relationship between the inhibition constant (K1) and the concentration of inhibitor which causes 50 per cent inhibition (I50) of an enzymatic reaction. Biochem Pharmacol 22:3099-3108.
5. Einolf HJ (2007) Comparison of different approaches to predict metabolic drug-drug interactions. Xenobiotica 37:1257-1294.
6. Fahmi OA, Maurer TS, Kish M, Cardenas E, Boldt S, and Nettleton D (2008) A combined model for predicting CYP3A4 clinical net drug-drug interaction based on CYP3A4 inhibition, inactivation and induction determined in vitro. Drug Metab Dispos 36:1698-1708.
7. Galetin A, Gertz M, and Houston JB (2008) Potential role of intestinal first-pass metabolism in the prediction of drug-drug interactions. Expert Opin Drug Metab Toxicol 4:909-922.
8. Gertz M, Kilford PJ, Houston JB, and Galetin A (2008) Drug lipophilicity and microsomal protein concentrations as determinants in the prediction of the fraction unbound in microsomal incubations. Drug Metab Dispos 36:535-542. (Pubitemid 351397979)
9. Greenblatt DJ, von Moltke LL, Perloff ES, Luo Y, Harmatz JS, and Zinny MA (2006) Interaction of flurbiprofen with cranberry juice, grape juice, tea and fluconazole: in vitro and clinical studies. Clin Pharmacol Ther 79:125-133. (Pubitemid 43071237)
10. Ito K, Brown HS, and Houston JB (2004) Database analyses for the prediction of in vivo drug-drug interactions from in vitro data. Brit J Clin Pharmacol 57:473-486. (Pubitemid 38519653)
11. Keogh JP and Kunta JR (2006) Development, validation and utility of an in vitro technique for assessment of potential clinical drug-drug interactions involving P-glycoprotein. Eur J Pharm Sci 27:543-554. (Pubitemid 43372051)
12. Krayenbühl JC, Vozeh S, Kondo-Oestreicher M, and Dayer P (1999) Drug-drug interactions of new active substances: mibefradil example. Eur J Clin Pharmacol 55:559-565. (Pubitemid 29489201)
13. Lilja JJ, Kivistö KT, and Neuvonen PJ (1998) Grapefruit juice-simvastatin interaction: effect on serum concentrations of simvastatin, simvastatin acid, and HMG-CoA reductase inhibitors. Clin Pharmacol Ther 64:477-483. (Pubitemid 28531591)
14. Lilja JJ, Kivistö KT, and Neuvonen PJ (1999) Grapefruit juice increases serum concentrations of atorvastatin and has no effect on pravastatin. Clin Pharmacol Ther 66:118-127. (Pubitemid 29398847)
15. Lilja JJ, Neuvonen M, and Neuvonen PJ (2004) Effects of regular consumption of grapefruit juice on the pharmacokinetics of simvastatin. Br J Clin Pharmacol 58:56-60. (Pubitemid 38901467)
16. Mayhew BS, Jones DR, and Hall SD (2000) An in vitro model for predicting in vivo inhibition of cytochrome P450 3A4 by metabolic intermediate complex formation. Drug Metab Dispos 28:1031-1037. (Pubitemid 30660356)
17. McGinnity DF, Waters NJ, Tucker J, and Riley RJ (2008) Integrated in vitro analysis for the in vivo prediction of cytochrome P450-mediated drug-drug interactions. Drug Metab Dispos 36:1126-1134. (Pubitemid 351717471)
18. Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, and Cantilena LR Jr (1990) Torsades de pointes occurring in association with terfenadine use. JAMA 264:2788-2790.
19. Obach RS (2009) Predicting drug-drug interactions from in vitro drug metabolism data: challenges and recent advances. Curr Opin Drug Discov Devel 12:81-89.
20. Obach RS, Walsky RL, and Venkatakrishnan K (2007) Mechanism-based inactivation of human cytochrome P450 enzymes and the prediction of drug-drug interactions. Drug Metab Dispos 35:246-255. (Pubitemid 46148737)
21. Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, and Tremaine LM (2006) The utility of in vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions. J Pharmacol Exp Ther 316:336-348. (Pubitemid 41832613)
22. Ohno Y, Hisaka A, and Suzuki H (2007) General framework for the quantitative prediction of CYP3A4-mediated oral drug interactions based on AUC increase by coadministration of standard drugs. Clin Pharmacokinet 46:681-696. (Pubitemid 47204854)
23. Olkkola KT, Ahonen J, and Neuvonen PJ (1996) The effects of the systemic antimycotics, itraconazole and fluconazole, on the pharmacokinetics and pharmacodynamics of intravenous and oral midazolam. Anesth Analg 82:511-516. (Pubitemid 26072953)
24. Polasek TM and Miners JO (2007) In vitro approaches to investigate mechanism-based inactivation of CYP enzymes. Expert Opin Drug Metab Toxicol 3:321-329. (Pubitemid 47316027)
25. Reese MJ, Wurm RM, Muir KT, Generaux GT, St John-Williams L, and McConn DJ (2008) An in vitro mechanistic study to elucidate the desipramine/bupropion clinical drug-drug interaction. Drug Metab Dispos 36:1198-1201. (Pubitemid 351929331)
26. Rowland M and Matin S (1973) Kinetics of drug-drug interactions. J Pharmacokinet Biopharm 1:553-566.
27. Tateishi T, Miura M, Suzuki T, and Uno T (2008) The different effects of itraconazole on the pharmacokinetics of fexofenadine enantiomers. Br J Clin Pharmacol 65:693-700. (Pubitemid 351535095)
28. Venkatakrishnan K and Obach RS (2005) In vitro-in vivo extrapolation of CYP2D6 inactivation by paroxetine: prediction of nonstationary pharmacokinetics and drug interaction magnitude. Drug Metab Dispos 33:845-852. (Pubitemid 40686639)
29. Venkatakrishnan K, Obach RS, and Rostami-Hodjegan A (2007) Mechanism-based inactivation of human cytochrome P450 enzymes: strategies for diagnosis and drug-drug interaction risk assessment. Xenobiotica 37:1225-1256. (Pubitemid 350035532)
30. Wang JS, Neuvonen M, Wen X, Backman JT, and Neuvonen PJ (2002) Gemfibrozil inhibits CYP2C8-mediated cerivastatin metabolism in human liver microsomes. Drug Metab Dispos 30:1352-1356. (Pubitemid 35397037)
31. Wang YH, Jones DR, and Hall SD (2004) Prediction of cytochrome P450 3A inhibition by verapamil enantiomers and their metabolites. Drug Metab Dispos 32:259-266. (Pubitemid 38176944)
32. Yang J, Liao M, Shou M, Jamei M, Yeo KR, Tucker GT, and Rostami-Hodjegan A (2008) Cytochrome P450 turnover: regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions. Curr Drug Metab 9:384-394.
33. Zamuner S, Johnson BM, Pagliarusco S, Fina P, Peroni M, Fiore M, Adams LM, and Fernandes SA (2010) Effect of single and repeat doses of casopitant on the pharmacokinetics of CYP450 3A4 substrates midazolam and nifedipine. Br J Clin Pharmacol 70:537-546.
34. Zhou SF (2008) Drugs behave as substrates, inhibitors and inducers of human cytochrome P450 3A4. Curr Drug Metab 9:310-322.