Читать книгу Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations - Sheila Annie Peters - Страница 59

REFERENCES

Оглавление

1 Aninat, C. et al. (2006). Expression of cytochromes P450, conjugating enzymes and nuclear receptors in human hepatoma HepaRG cells. Drug Metabolism and Disposition 34 (1): 75–83. https://doi.org/10.1124/dmd.105.006759.

2 Atkinson, A., Kenny, J.R., and Grime, K. (2005). Automated assessment of time‐dependent inhibition of human cytochrome P450 enzymes using liquid chromatography‐tandem mass spectrometry analysis. Drug Metabolism and Disposition 33 (11): 1637–1647. https://doi.org/10.1124/dmd.105.005579.

3 Ayrton, A. and Morgan, P. (2001). Role of transport proteins in drug absorption, distribution and excretion. Xenobiotica 31 (8–9): 469–497. https://doi.org/10.1080/00498250110060969.

4 Backman, J.T. et al. (2005). Rifampin markedly decreases and gemfibrozil increases the plasma concentrations of atorvastatin and its metabolites. Clinical Pharmacology and Therapeutics 78 (2): 154–167. https://doi.org/10.1016/j.clpt.2005.04.007.

5 Bendayan, R. et al. (1990). Effect of cimetidine and ranitidine on the hepatic and renal elimination of nicotine in humans. European Journal of Clinical Pharmacology 38 (2): 165–169. https://doi.org/10.1007/BF00265978.

6 Chu, V. et al. (2009). In vitro and in vivo induction of cytochrome P450: A survey of the current practices and recommendations: A Pharmaceutical Research and Manufacturers of America perspective. Drug Metabolism and Disposition 37 (7): 1339–1354. https://doi.org/10.1124/dmd.109.027029.

7 Dunne, J. et al. (2011) ‘Extrapolation of adult data and other data in pediatric drug‐development programs’, Pediatrics, 128(5), p. e1242. doi: 10.1542/peds.2010‐3487.

8 El‐Sankary, W. et al. (2001). Use of a reporter gene assay to predict and rank the potency and efficacy of CYP3A4 inducers. Drug Metabolism and Disposition 29 (11): 1499–1504.

9 EMA (2013). Guideline on the investigation of drug interactions. In: London. https://www.ema.europa.eu/en/documents/scientific‐guideline/guideline‐investigation‐drug‐interactions‐revision‐1_en.pdf.

10 Fahmi, O.A. and Ripp, S.L. (2010). Evaluation of models for predicting drugdrug interactions due to induction. Expert Opinion on Drug Metabolism and Toxicology 6 (11): 1399–1416. https://doi.org/10.1517/17425255.2010.516251.

11 Franklin, M.R. (1991). Cytochrome P450 metabolic intermediate complexes from macrolide antibiotics and related compounds. Methods in Enzymology 206 (C): 559–573. https://doi.org/10.1016/0076‐6879(91)06126‐N.

12 Galetin, A. et al. (2006). Prediction of time‐dependent CYP3A4 drug‐drug interactions: Impact of enzyme degradation, parallel elimination pathways, and intestinal inhibition. Drug Metabolism and Disposition 34 (1): 166–175. https://doi.org/10.1124/dmd.105.006874.

13 Grime, K.H. et al. (2009). Mechanism‐based inhibition of cytochrome P450 enzymes: An evaluation of early decision making in vitro approaches and drug‐drug interaction prediction methods. European Journal of Pharmaceutical Sciences 36 (2–3): 175–191. https://doi.org/10.1016/j.ejps.2008.10.002.

14 Grimm, S.W. et al. (2009). The conduct of in vitro studies to address time‐dependent inhibition of drug‐metabolizing enzymes: A perspective of the Pharmaceutical Research and Manufacturers of America. Drug Metabolism and Disposition 37 (7): 1355–1370. https://doi.org/10.1124/dmd.109.026716.

15 Harper, T.W. and Brassil, P.J. (2008). Reaction phenotyping: Current industry efforts to identify enzymes responsible for metabolizing drug candidates. AAPS Journal 10 (1): 200–207. https://doi.org/10.1208/s12248‐008‐9019‐6.

16 Ho, R.H. and Kim, R.B. (2005). Transporters and drug therapy: Implications for drug disposition and disease. Clinical Pharmacology and Therapeutics 78 (3): 260–277. https://doi.org/10.1016/j.clpt.2005.05.011.

17 Hollenberg, P.F., Kent, U.M., and Bumpus, N.N. (2008). Mechanism‐based inactivation of human cytochromes P450s: Experimental characterization, reactive intermediates, and clinical implications. Chemical Research in Toxicology: 189–205. https://doi.org/10.1021/tx7002504.

18 Inotsume, N. et al. (1990). The inhibitory effect of probenecid on renal excretion of famotidine in young, healthy volunteers. Journal of Clinical Pharmacology 30 (1): 50–56. https://doi.org/10.1002/j.1552‐4604.1990.tb03438.x.

19 Ivanyuk, A. et al. (2017). Renal drug transporters and drug interactions. Clinical Pharmacokinetics: 825–892. https://doi.org/10.1007/s40262‐017‐0506‐8.

20 Jing, X. et al. (2020) ‘Update on therapeutic protein–drug interaction: Information in labeling’, Clinical Pharmacokinetics. 59(1), pp. 25–36. doi: 10.1007/s40262‐019‐00810‐z.

21 Jones, N.S. et al. (2020). Complex DDI by fenebrutinib and the use of transporter endogenous biomarkers to elucidate the mechanism of DDI. Clinical Pharmacology and Therapeutics 107 (1): 269–277. https://doi.org/10.1002/cpt.1599.

22 Kalgutkar, A.S., Obach, R.S., and Maurer, T.S. (2007). Mechanism‐based inactivation of cytochrome P450 enzymes: Chemical mechanisms, structure‐activity relationships and relationship to clinical drug‐drug interactions and idiosyncratic adverse drug reactions. Current Drug Metabolism 8 (5): 407–447. https://doi.org/10.2174/138920007780866807.

23 Kanebratt, K.P. and Andersson, T.B. (2008). HepaRG cells as an in vitro model for evaluation of cytochrome P450 induction in humans. Drug Metabolism and Disposition 36 (1): 137–145. https://doi.org/10.1124/dmd.107.017418.

24 Kato, M. et al. (2005). The quantitative prediction of in vivo enzyme‐induction caused by drug exposure from in vitro information on human hepatocytes. Drug Metabolism and Pharmacokinetics 20 (4): 236–243. https://doi.org/10.2133/dmpk.20.236.

25 Kenny, J. R., Ramsden D., Buckley, D. B. et al. (2018). Considerations from the Innovation and Quality Induction Working Group in Response to Drug‐Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance. Drug Metabolism and Disposition. 46 (9): 1285–1303. https://doi.org/10.1124/dmd.118.081927.

26 Kirch, W. et al. (1987). Pharmacokinetics of bisoprolol during repeated oral administration to healthy volunteers and patients with kidney or liver disease. Clinical Pharmacokinetics 13 (2): 110–117. https://doi.org/10.2165/00003088‐198713020‐00003.

27 Lau, Y.Y. et al. (2007). Effect of OATP1B transporter inhibition on the pharmacokinetics of atorvastatin in healthy volunteers. Clinical Pharmacology and Therapeutics 81 (2): 194–204. https://doi.org/10.1038/sj.clpt.6100038.

28 LeCluyse, E. et al. (2000). Expression and regulation of cytochrome P450 enzymes in primary cultures of human hepatocytes. Journal of Biochemical and Molecular Toxicology 14 (4): 177–188. https://doi.org/10.1002/(SICI)1099‐0461(2000)14:4<177::AID‐JBT1>3.0.CO;2‐4.

29 Luo, G. et al. (2005). CYP3A4 induction by xenobiotics: biochemistry, experimental methods and impact on drug discovery and development. Current Drug Metabolism 5 (6): 483–505. https://doi.org/10.2174/1389200043335397.

30 MHLW (Ministry of Health, Labour and Welfare). 2018. Guideline on drug interaction for drug development and appropriate provision of information (final draft), MHLW, Tokyo, Japan. https://www.pmda.go.jp/files/000228122.pdf.

31 Mills, J.B. et al. (2004). Induction of drug metabolism enzymes and MDR1 using a novel human hepatocyte cell line. Journal of Pharmacology and Experimental Therapeutics 309 (1): 303–309. https://doi.org/10.1124/jpet.103.061713.

32 Obach, R.S., Walsky, R.L., and Venkatakrishnan, K. (2007). Mechanism‐based inactivation of human cytochrome P450 enzymes and the prediction of drug‐drug interactions. Drug Metabolism and Disposition 35 (2): 246–255. https://doi.org/10.1124/dmd.106.012633.

33 Persson, K.P. et al. (2006). Evaluation of human liver slices and reporter gene assays as systems for predicting the cytochrome P450 induction potential of drugs in vivo in humans. Pharmaceutical Research 23 (1): 56–69. https://doi.org/10.1007/s11095‐005‐8812‐5.

34 Riley, R.J., Grime, K., and Weaver, R. (2007). Time‐dependent CYP inhibition. Expert Opinion on Drug Metabolism and Toxicology: 51–66. https://doi.org/10.1517/17425255.3.1.51.

35 Shitara, Y. et al. (2009). Long‐lasting inhibition of the transporter‐mediated hepatic uptake of sulfobromophthalein by cyclosporin A in rats. Drug Metabolism and Disposition 37 (6): 1172–1178. https://doi.org/10.1124/dmd.108.025544.

36 Silverman, R.B. and Hiebert, C.K. (1988). Inactivation of monoamine oxidase A by the monoamine oxidase B inactivators 1‐phenylcyclopropylamine, 1‐benzylcyclopropylamine, and N‐cyclopropyl‐α‐methylbenzylamine. Biochemistry 27 (22): 8448–8453. https://doi.org/10.1021/bi00422a023.

37 Sinz, M. et al. (2006). Evaluation of 170 Xenobiotics as transactivators of human pregnane X receptor (hPXR) and correlation to known CYP3A4 drug interactions. Current Drug Metabolism 7 (4): 375–388. https://doi.org/10.2174/138920006776873535.

38 Somogyi, A. et al. (1987). Reduction of metformin renal tubular secretion by cimetidine in man. British Journal of Clinical Pharmacology 23 (5): 545–551. https://doi.org/10.1111/j.1365‐2125.1987.tb03090.x.

39 USFDA (2020a). Clinical drug interaction studies Cytochrome P450 enzyme‐ and transporter‐mediated drug interactions ‐ Guidance for industry. Silver Spring, January 2020. https://www.fda.gov/media/134581/download.

40 USFDA (2020b). In vitro drug interaction studies: Cytochrome p450 enzyme‐ and transporter‐mediated drug interactions Guidance for industry. Silver Spring, January 2020. https://www.fda.gov/media/134582/download.

41 USFDA (2020c). Drug-drug interaction assessment for therapeutic proteins. Guidance for Industry. Silver Spring, August 2020. https://www.fda.gov/media/140909/download.

42 Venkatakrishnan, K. et al. (2005). Drug metabolism and drug interactions: application and clinical value of in vitro models. Current Drug Metabolism 4 (5): 423–459. https://doi.org/10.2174/1389200033489361.

43 Venkatakrishnan, K. and Obach, R.S. (2007). Drug‐drug interactions via mechanism‐based cytochrome P450 inactivation: Points to consider for risk assessment from in vitro data and clinical pharmacologic evaluation. Current Drug Metabolism 8 (5): 449–462. https://doi.org/10.2174/138920007780866861.

44 Watanabe, A. et al. (2007). Risk assessment for drug‐drug interaction caused by metabolism‐based inhibition of CYP3A using automated in vitro assay systems and its application in the early drug discovery process. Drug Metabolism and Disposition 35 (7): 1232–1238. https://doi.org/10.1124/dmd.107.015016.

45 Wu, K.C. and Lin, C.J. (2019). The regulation of drug‐metabolizing enzymes and membrane transporters by inflammation: Evidences in inflammatory diseases and age‐related disorders. Journal of Food and Drug Analysis 27 (1): 48–59. https://doi.org/10.1016/j.jfda.2018.11.005.

46 Yang, J. et al. (2008). Cytochrome P450 turnover: Regulation of synthesis and degradation, methods for determining rates, and implications for the prediction of drug interactions. Current Drug Metabolism 9 (5): 384–393. https://doi.org/10.2174/138920008784746382.

47 Yung‐Chi, C. and Prusoff, W.H. (1973). Relationship between the inhibition constant (KI) and the concentration of inhibitor which causes 50 per cent inhibition (I50) of an enzymatic reaction. Biochemical Pharmacology 22 (23): 3099–3108. https://doi.org/10.1016/0006‐2952(73)90196‐2.

48 Zhang, X. et al. (2009). Semiphysiologically based pharmacokinetic models for the inhibition of midazolam clearance by diltiazem and its major metabolite. Drug Metabolism and Disposition 37 (8): 1587–1597. https://doi.org/10.1124/dmd.109.026658.

Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations

Подняться наверх