吸収、分布、代謝、排泄
・鼻腔からの吸収に関する論文です。
Kozlovskaya L et al. Quantitative analysis of drug delivery to the brain via nasal route. J Control Release 189:133-140, 2014.
Turker S et al. Nasal route and drug delivery systems. Pharm World Sci 26:137-142, 2004.
Ozsoy Y et al. Nasal delivery of high molecular weight drugs. Molecules 14:3754-3779, 2009.
Arora P et al. Permeability issues in nasal drug delivery. Drug Discov Today 7:967-975, 2002.
・口腔からの吸収に関する論文です。
Shojaei AH Buccal mucosa as a route for systemic drug delivery: a review. J Pharm Pharm Sci 1:15-30, 1998.
・Motwani JG Clinical pharmacokinetics of drug administered buccally and sublingually. Clin Pharamcokinet 21:83-94, 1991.
・消化管からの吸収に関する論文です。
Morishita M, Peppas NA Is the oral route possible for peptide and protein drug delivery? Drug Discov Today 11:905-910, 2006.
Pang KS Modeling of intestinal drug absorption: roles of transporters and metabolic enzymes (for the Gillette Review Series). Drug Metab Dispos 31:1507-1519, 2003.
Tam D et al. Segmental intestinal transporters and metabolic enzymes on intestinal drug absorption. Drug Metab Dispos 31:373-383, 2003.
・直腸からの吸収に関する論文です。
Kurosawa N et al. Avoidance of hepatic first-pass effect in the rabbit via rectal route of administration. Biopharm Drug Dispos 19:589-594,
1998.
van Hoogdalem EJ et al. Pharmacokinetics of rectal drug administration, Part II. Clinical applications of peripherally acting drugs, and conclusions. Clin Pharmacokinet 21:110-128, 1991.
・van Hoogdalem E et al. Pharmacokinetics of rectal drug administration, Part I. General considerations and clinical applications of centrally
acting drugs. Clin Pharmacokinet 21:11-26, 1991.
・膣からの吸収に関する論文です。
Vermani K, Garg S. The scope and potential of vaginal drug delivery. Pharm Sci Technolo Today 3:359-364, 2000.
Hussain A, Ahsan F. The vagina as a route for systemic drug delivery. J Control Release 103:301-313, 2005.
- 分布に関する論文です。
Yun YE, Edginton AN. Correlation-based prediction of tissue-to-plasma partition coefficients using readily available input parameters. Xenobiotica 43:839-852, 2013. - 眼の動態に関する論文です。
Urtti A. Challenges and obstacles of ocular pharmacokinetics and drug delivery. Adv Drug Deliv Rev 58:1131-1135, 2006.
Gaudana R et al. Ocular drug delivery. AAPS J 12:348-360, 2010.
Agrahari V et al. A comprehensive insight on ocular pharmacokinetics. Drug Deliv Transl Res 6:735-754, 2016. - 「眼のメラニン色素に対する薬物の結合は必ずしも眼毒性の誘発を示唆するものではない」ことを主張したいときの定番引用文献です。
Leblanc B et al. Binding of drugs to eye melanin is not predictive of ocular toxicity. Regul Toxicol Pharmacol 28:124-132, 1998. - 代謝に関する論文です。
Bogaards JJ et al. Determining the best animal model for human cytochrome P450 activities: a comparison of mouse, rat, rabbit, dog, micropig, monkey and man. Xenobiotica 30:1131-1152, 2000.
Murray M, Reidy GF. Selectivity in the inhibition of mammalian cytochromes P-450 by chemical agents. Pharmacol Rev 42:85-101, 1990.
Martignoni M ey al. Species differences between mouse, rat, dog, monkey and human CYP-mediated drug metabolism, inhibition and induction. Expert Opin Drug Metab Toxicol 2:875-894, 2006.
Sakai C et al. Species Differences in the Pharmacokinetic Parameters of Cytochrome P450 Probe Substrates between Experimental Animals, such as Mice, Rats, Dogs, Monkeys, and Microminipigs, and Humans. J Drug Metab Toxicol 5:173. doi: 10.4172/2157-7609.1000173.
Bogaards JJ et al. Determining the best animal model for human cytochrome P450 activities: a comparison of mouse, rat, rabbit, dog, micropig, monkey and man. Xenobiotica 30:1131-1152, 2000.
Kitamura S, Sugihara K. Current status of prediction of drug disposition and toxicity in humans using chimeric mice with humanized liver. Xenobiotica 44:123-134, 2014.
Saghir SA et al. Ontogeny of mammalian metabolizing enzymes in humans and animals used in toxicological studies. Crit Rev Toxicol 42:323-357, 2012.
Jones CR et al. Gut Wall Metabolism. Application of Pre-Clinical Models for the Prediction of Human Drug Absorption and First-Pass Elimination. AAPS J 18:589-604, 2016.
Xie F et al. An update on the role of intestinal cytochrome P450 enzymes in drug disposition. Acta Pharm Sin B 6:374-383, 2016.
Nishimuta H et al. Species differences in hepatic and intestinal metabolic activities for 43 human cytochrome P450 substrates between humans and rats or dogs. Xenobiotica 43:948-955, 2013. - 医薬品開発に際して検討が必要なトランスポーターを整理したバイブル的な文献です。
International Transporter Consortium. Membrane transporters in drug development. Nat Rev Drug Discov 9:215-236, 2010. - PBPKに関する総説です。
Huang SM et al. The utility of modeling and simulation in drug development and regulatory review. J Pharm Sci 102:2912-2923, 2013.
Huang SM, Rowland M. The role of physiologically based pharmacokinetic modeling in regulatory review. Clin Pharmacol Ther 91:542-549, 2012.
Zhao P et al. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther 92:17-20, 2012.
Zhao P et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther 89:259-267, 2011.
Smith BJ. An industrial perspective on contemporary applications of PBPK models in drug discovery and development. Biopharm Drug Dispos 33:53-54, 2012.
薬物動態学的相互作用
- トランスポーターに関連する薬物相互作用Drug-Drug Interaction =DDIについて，規制当局側と企業側の双方の立場からの見解を知ることができます。
Zhang L et al. A regulatory viewpoint on transporter-based drug interactions. Xenobiotica 38:709-724, 2008.
- CYPレベルでのDDIに関する論文です。
トランスポーターに関連する薬物相互作用Drug-Drug Interaction =DDIについて，規制当局側と企業側の双方の立場からの見解を知ることができます。
Prueksaritanont T et al. Drug-drug interaction studies: regulatory guidance and an industry perspective. AAPS J 15:629-645, 2013.
Zhang L et al. A regulatory viewpoint on transporter-based drug interactions. Xenobiotica 38:709-724, 2008.
- CYPレベルでのDDIに関する論文です。
Vieira ML et al. Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor. Clin Pharmacol Ther 91:700-708, 2012.
Hedrich WD et al. Insights into CYP2B6-mediated drug-drug interactions. Acta Pharm Sin B 6:413-425, 2016. - 腎臓のトランスポーターレベルでのDDIに関する論文です。
Yin J, Wang J. Renal drug transporters and their significance in drug-drug interactions. Acta Pharm Sin B 6:363-373, 2016.