-
2
-
-
23444432195
-
Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan
-
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
-
-
Uyama, Y.1
Shibata, T.2
Nagai, N.3
Hanaoka, H.4
Toyoshima, S.5
Mori, K.6
-
3
-
-
81355135357
-
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
-
-
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
-
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
-
-
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
-
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
-
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
-
-
49949090275
-
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
-
-
84880708171
-
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).
-
(2011)
The Asia-Pacific Economic Cooperation Multiregional Clinical Trials Workshop
-
-
Tohkin, M.1
|