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Volumn 94, Issue 2, 2013, Pages 195-198

Regulatory challenges in the review of data from global clinical trials: The PMDA perspective

Author keywords

[No Author keywords available]

Indexed keywords

APIXABAN; ATOMOXETINE; DENOSUMAB; FESOTERODINE; NEW DRUG;

EID: 84880752966     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.106     Document Type: Review
Times cited : (36)

References (12)
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    • DOI 10.1016/j.clpt.2005.04.001, PII S0009923605001669
    • Uyama, Y., Shibata, T., Nagai, N., Hanaoka, H., Toyoshima, S. & Mori, K. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin. Pharmacol. Ther. 78, 102-113 (2005). (Pubitemid 41112277)
    • (2005) Clinical Pharmacology and Therapeutics , vol.78 , Issue.2 , pp. 102-113
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  • 3
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    • Approaches to Japanese dose evaluation in global drug development: Factors that generate different dosages between Japan and the United States
    • Nakashima, K., Narukawa, M. & Takeuchi, M. Approaches to Japanese dose evaluation in global drug development: factors that generate different dosages between Japan and the United States. Clin. Pharmacol. Ther. 90, 836-843 (2011).
    • (2011) Clin. Pharmacol. Ther , vol.90 , pp. 836-843
    • Nakashima, K.1    Narukawa, M.2    Takeuchi, M.3
  • 4
    • 70449660319 scopus 로고    scopus 로고
    • Ministry of Health, Labour, and Welfare Notification 0928010 28 September
    • Ministry of Health, Labour, and Welfare. Basic principles on global clinical trials. Notification 0928010 http://www.pmda.go.jp/kijunsakusei/file/ guideline/new-drug/GlobalClinicalTrials-en.pdf (28 September 2007).
    • (2007) Basic Principles on Global Clinical Trials
  • 5
    • 84866293681 scopus 로고    scopus 로고
    • Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects
    • Ando, Y. & Uyama, Y. Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects. J. Biopharm. Stat. 22, 977-987 (2012).
    • (2012) J. Biopharm. Stat , vol.22 , pp. 977-987
    • Ando, Y.1    Uyama, Y.2
  • 6
    • 84880710327 scopus 로고    scopus 로고
    • Ministry of Health, Labour, and Welfare Administrative Notice 5 September
    • Ministry of Health, Labour, and Welfare. Basic principles on global clinical trials (reference cases). Administrative Notice http://www.pmda.go.jp/ kijunsakusei/file/guideline/new-drug/GCT-jirei-en.pdf (5 September 2012).
    • (2012) Basic Principles on Global Clinical Trials (Reference Cases)
  • 9
    • 84880728271 scopus 로고    scopus 로고
    • Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: An FDA perspective
    • Khin, N.A. et al. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. Clin. Pharmacol. Ther. 94, 230-242 (2013).
    • (2013) Clin. Pharmacol. Ther , vol.94 , pp. 230-242
    • Khin, N.A.1
  • 10
    • 56749161670 scopus 로고    scopus 로고
    • Emerging ethnic differences in lung cancer therapy
    • Sekine, I., Yamamoto, N., Nishio, K. & Saijo, N. Emerging ethnic differences in lung cancer therapy. Br. J. Cancer 99, 1757-1762 (2008).
    • (2008) Br. J. Cancer , vol.99 , pp. 1757-1762
    • Sekine, I.1    Yamamoto, N.2    Nishio, K.3    Saijo, N.4
  • 11
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    • The role of ethnicity in variability in response to drugs: Focus on clinical pharmacology studies
    • Yasuda, S.U., Zhang, L. & Huang, S.M. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin. Pharmacol. Ther. 84, 417-423 (2008).
    • (2008) Clin. Pharmacol. Ther , vol.84 , pp. 417-423
    • Yasuda, S.U.1    Zhang, L.2    Huang, S.M.3
  • 12
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    • Comparative studies of pharmacokinetics among East Asian populations moxifloxacin, simvastatin, meloxicam
    • November 1st 2011, Tokyo, Japan
    • Tohkin, M. Comparative studies of pharmacokinetics among East Asian populations moxifloxacin, simvastatin, meloxicam. Presented at the Asia-Pacific Economic Cooperation multiregional clinical trials workshop, November 1st, 2011, Tokyo, Japan. http://www.pmda.go.jp/english/past/2011apec-workshop/file/2- 2Masahiro-Tohkin.pdf (2011).
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    • Tohkin, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.