よむ、つかう、まなぶ。
【資料No.1】2.4_非臨床試験の概括資料 (32 ページ)
出典
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会（令和4年度第5回 11／22）、医薬品第二部会（令和4年度第13回 11／22）（合同開催）《厚生労働省》 |
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S-217622
2.4 非臨床の概括評価
https://www.certara.com/app/uploads/Resources/Posters/Ke_2017_ASCPT_CYP2B6.pdf
12. Fowler S, Morcos P, Cleary Y, et al. Progress in prediction and interpretation of clinically relevant
metabolic drug-drug interactions: A minireview illustrating recent developments and current
opportunities. Curr Pharmacol Rep 2017;3(1):36-49.
13. Chiba K, Shimizu K, Kato M, et al. Estimation of interindividual variability of pharmacokinetics of
CYP2C9 substrates in humans. J Pharm Sci 2017;106(9):2695-703.
14. Cuypers ML, Chanteux H, Gillent E, et al. (-)- N-3-benzylphenobarbital is superior to omeprazole and
(+)- N-3-benzylnirvanol as a CYP2C19 inhibitor in suspended human hepatocytes. Drug Metab Dispos
2020;48(11):1121-8.
15. VandenBrink BM, Foti RS, Rock DA, Wienkers LC, Wahlstrom JL. Prediction of CYP2D6 drug
interactions from in vitro data: evidence for substrate-dependent inhibition. Drug Metab Dispos
2012;40(1):47-53.
16. Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, Tremaine LM. The utility of in
vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions. J Pharmaco Exp Ther
2006;316(1):336-48.
17. Koch-Weser J, Sellers EM. Binding of drugs to serum albumin (first of two parts). N Engl J Med
1976;294:311-6.
18. 検査値アプローチ 3. 基準範囲・臨床判断値．In：一般社団法人 日本臨床検査医学会．臨床
検査のガイドライン JSLM2018 検査値アプローチ/症候/疾患．宇宙堂八木書店; 2018．p14.
19. Robichaud A, Tattersall FD, Choudhury I, Rodger IW. Emesis induced by inhibitors of type IV cyclic
nucleotide phosphodiesterase (PDE IV) in the ferret. Neuropharmacology 1999;38:289–97.
20. Heaslip RJ, Evans DY. Emetic, central nervous system, and pulmonary activities of rolipram in the dog.
Eur J Pharmacol 1995;286:281-90.
21. Losco PE, Evans EW, Barat SA, et al. The toxicity of SCH 351591, a novel phosphodiesterase-4
inhibitor, in cynomolgus monkeys. Toxicol Pathol 2004;32:295–308.
22. Zussman BD, Benincosa LJ, Webber DM, et al. An overview of the pharmacokinetics of cilomilast
(Ariflo®), a new, orally active phosphodiesterase 4 inhibitor, in healthy young and elderly volunteers. J
Clin Pharmacol 2001;41:950-58.
23. Chamanza R, Marxfeld HA, Blanco AI, Naylor SW, Bradley AE. Incidences and range of spontaneous
findings in control cynomolgus monkeys (Macaca fascicularis) used in toxicity studies. Toxicol Pathol
2010;38:642-57.
24. Colman K, Andrews RN, Atkins H, et al. International harmonization of nomenclature and diagnostic
criteria (INHAND): Non-proliferative and proliferative lesions of the non-human primate (M.
fascicularis). J Toxicol Pathol 2021;34(3 Suppl):1S-182S.
25. Keppler D. The roles of MRP2, MRP3, OATP1B1, and OATP1B3 in conjugated hyperbilirubinemia.
Drug Metab Dispos 2014;42:561–5.
26. Wickramaratne GAS. The post-natal fate of supernumerary ribs in rat teratogenicity studies. J Appl
Toxicol 1988;8(2):91-4.
32
2.4 非臨床の概括評価
https://www.certara.com/app/uploads/Resources/Posters/Ke_2017_ASCPT_CYP2B6.pdf
12. Fowler S, Morcos P, Cleary Y, et al. Progress in prediction and interpretation of clinically relevant
metabolic drug-drug interactions: A minireview illustrating recent developments and current
opportunities. Curr Pharmacol Rep 2017;3(1):36-49.
13. Chiba K, Shimizu K, Kato M, et al. Estimation of interindividual variability of pharmacokinetics of
CYP2C9 substrates in humans. J Pharm Sci 2017;106(9):2695-703.
14. Cuypers ML, Chanteux H, Gillent E, et al. (-)- N-3-benzylphenobarbital is superior to omeprazole and
(+)- N-3-benzylnirvanol as a CYP2C19 inhibitor in suspended human hepatocytes. Drug Metab Dispos
2020;48(11):1121-8.
15. VandenBrink BM, Foti RS, Rock DA, Wienkers LC, Wahlstrom JL. Prediction of CYP2D6 drug
interactions from in vitro data: evidence for substrate-dependent inhibition. Drug Metab Dispos
2012;40(1):47-53.
16. Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, Tremaine LM. The utility of in
vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions. J Pharmaco Exp Ther
2006;316(1):336-48.
17. Koch-Weser J, Sellers EM. Binding of drugs to serum albumin (first of two parts). N Engl J Med
1976;294:311-6.
18. 検査値アプローチ 3. 基準範囲・臨床判断値．In：一般社団法人 日本臨床検査医学会．臨床
検査のガイドライン JSLM2018 検査値アプローチ/症候/疾患．宇宙堂八木書店; 2018．p14.
19. Robichaud A, Tattersall FD, Choudhury I, Rodger IW. Emesis induced by inhibitors of type IV cyclic
nucleotide phosphodiesterase (PDE IV) in the ferret. Neuropharmacology 1999;38:289–97.
20. Heaslip RJ, Evans DY. Emetic, central nervous system, and pulmonary activities of rolipram in the dog.
Eur J Pharmacol 1995;286:281-90.
21. Losco PE, Evans EW, Barat SA, et al. The toxicity of SCH 351591, a novel phosphodiesterase-4
inhibitor, in cynomolgus monkeys. Toxicol Pathol 2004;32:295–308.
22. Zussman BD, Benincosa LJ, Webber DM, et al. An overview of the pharmacokinetics of cilomilast
(Ariflo®), a new, orally active phosphodiesterase 4 inhibitor, in healthy young and elderly volunteers. J
Clin Pharmacol 2001;41:950-58.
23. Chamanza R, Marxfeld HA, Blanco AI, Naylor SW, Bradley AE. Incidences and range of spontaneous
findings in control cynomolgus monkeys (Macaca fascicularis) used in toxicity studies. Toxicol Pathol
2010;38:642-57.
24. Colman K, Andrews RN, Atkins H, et al. International harmonization of nomenclature and diagnostic
criteria (INHAND): Non-proliferative and proliferative lesions of the non-human primate (M.
fascicularis). J Toxicol Pathol 2021;34(3 Suppl):1S-182S.
25. Keppler D. The roles of MRP2, MRP3, OATP1B1, and OATP1B3 in conjugated hyperbilirubinemia.
Drug Metab Dispos 2014;42:561–5.
26. Wickramaratne GAS. The post-natal fate of supernumerary ribs in rat teratogenicity studies. J Appl
Toxicol 1988;8(2):91-4.
32