Translational and Clinical Pharmacology

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Regional clinical pharmacology trials for Multi-Regional clinical trials

  • Jang, In-Jin (Department of Clinical Pharmacology and Therapeutics College of Medicine, Seoul National University and Seoul National University Hospital, Clinical Trials Center, SNU Hospital)
  • Published : 2018.09.15
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Abstract

Keywords

References

  1. General principles for planning and design of Multi-Regional Clinical Trials. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/general-principle-on-planningdesigning-multi-regional-clinical-trials.html/ Accessed 1 July 2018
  2. ICH E17. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17EWG_Step4_2017_1116.pdf/ Accessed 1 July 2018
  3. Construction of Northeast Asian network. https://www.konect.or.kr/kr/contents/business_new_6/view.do/ Accessed 1 July 2018
  4. Hasunuma T, Tohkin M, Kaniwa N, Jang IJ, Yimin C, Kaneko M, et al. Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians. Br J Clin Pharmacol 2016;81:1078-1090. doi: 10.1111/bcp.12884.
  5. Jeon H, Jang IJ, Lee S, Ohashi K, Kotegawa T, Ieiri I, et al. Apple juice greatly reduces systemic exposure to atenolol. Br J Clin Pharmacol 2013;75:172-179. doi: 10.1111/j.1365-2125.2012.04324.x.
  6. Hor SY, Lee SC, Wong CI, Lim YW, Lim RC, Wang LZ, et al. PXR, CAR and HNF4alpha genotypes and their association with pharmacokinetics and pharmacodynamics of docetaxel and doxorubicin in Asian patients. Pharmacogenomics J 2008;8:139-146. https://doi.org/10.1038/sj.tpj.6500478
  7. Tamura M, Kondo M, Horio M, Ando M, Saito H, Yamamoto M, et al. Genetic polymorphisms of the adenosine triphosphate-binding cassette transporters (ABCG2, ABCB1) and gefitinib toxicity. Nagoya J Med Sci 2012;74:133-140.
  8. Arnold FL, Fukunaga S, Kusama M, Matsuki N, Ono S. Assessment of factors associated with dose differences between Japan and the United States. Clin Pharmacol Ther 2014;95:542-549. doi: 10.1038/clpt.2013.231.

Cited by

  1. The necessary conduct: Exploratory multiregional clinical trials in East Asia vol.14, pp.6, 2018, https://doi.org/10.1111/cts.13106