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Volumn 87, Issue 2, 2010, Pages 212-218

Delays in new drug applications in Japan and industrial RandD strategies

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 75749100539     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.215     Document Type: Article
Times cited : (56)

References (14)
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    • (2007) Iryo to Shakai , vol.17 , pp. 243-258
    • Tsuji, K.1    Tsutani, K.2
  • 3
    • 14944376871 scopus 로고    scopus 로고
    • The impact of price regulation on the launch delay of new drugs-evidence from twenty-fve major markets in the 1990s
    • Danzon, P.M., Wang, Y.R., & Wang, L. The impact of price regulation on the launch delay of new drugs-evidence from twenty-fve major markets in the 1990s. Health Econ. 14, 269-292 (2005).
    • (2005) Health Econ. , Issue.14 , pp. 269-292
    • Danzon, P.M.1    Wang, Y.R.2    Wang, L.3
  • 4
    • 34547760765 scopus 로고    scopus 로고
    • Patient access to pharmaceuticals: An international comparison
    • Cohen, J., faden, L., & Predaris, S. Patient access to pharmaceuticals: an international comparison. Eur. J. Health Econ. 8, 253-266 (2007).
    • (2007) Eur. J. Health Econ. , vol.8 , pp. 253-266
    • Cohen, J.1    Faden, L.2    Predaris, S.3
  • 5
    • 60049098391 scopus 로고    scopus 로고
    • History of the discussion on ethnic diference at ICH
    • in Japanese
    • Uchida, E. History of the discussion on ethnic diference at ICH. Yakugaku Zasshi 129, 213-221 (2009) (in Japanese).
    • (2009) Yakugaku Zasshi , vol.129 , pp. 213-221
    • Uchida, E.1
  • 6
    • 75749129496 scopus 로고    scopus 로고
    • Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare, & Ministry of Economy, Trade and Industry. five-year Strategy for Creation of Innovative Drugs and Medical Devices, april 2007, revised May 2008 and february 2009 (in Japanese)
    • Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare, & Ministry of Economy, Trade and Industry. five-year Strategy for Creation of Innovative Drugs and Medical Devices, april 2007, revised May 2008 and february 2009 (in Japanese).
  • 7
    • 75749153016 scopus 로고    scopus 로고
    • New drug development times in Japan. Time of clinical development and approval
    • Research Paper No. 42, September in Japanese
    • Yasuda, K. & Ono, S. New drug development times in Japan. Time of clinical development and approval. Ofce of Pharmaceutical Research. Research Paper No. 42, September 2008 (in Japanese).
    • (2008) Ofce of Pharmaceutical Research
    • Yasuda, K.1    Ono, S.2
  • 8
    • 75749101472 scopus 로고    scopus 로고
    • Survey on "drug lag" in Japan
    • Research Paper No. 40, June in Japanese
    • Ishibashi, K. Survey on "drug lag" in Japan. Ofce of Pharmaceutical Research. Research Paper No. 40, June 2008 (in Japanese).
    • (2008) Ofce of Pharmaceutical Research
    • Ishibashi, K.1
  • 9
    • 75749153015 scopus 로고    scopus 로고
    • Drug lag of clinical importance
    • in Japanese
    • Tsuji, K. & Tsutani, K. Drug lag of clinical importance. Jpn. J. Clin. Pharmacol. Ther. 39 (suppl.), S266 (2008) (in Japanese).
    • (2008) Jpn. J. Clin. Pharmacol. Ther. , vol.39 , Issue.SUPPL.
    • Tsuji, K.1    Tsutani, K.2
  • 10
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola, I. & Landis, J. Can the pharmaceutical industry reduce attrition rates? Nature Rev. Drug Discov. 3, 711-715 (2004).
    • (2004) Nature Rev Drug Discov. , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 11
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    • The role of frm characteristics in pharmaceutical product launches
    • Kyle, M.K. The role of frm characteristics in pharmaceutical product launches. Rand J. Econ. 37, 602-618 (2006).
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    • Kyle, M.K.1
  • 12
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    • Ministry of Health and Welfare Pharmaceutical and Food Safety Bureau Notifcation No. 0928010 on Basic Concepts for Joint International Clinical Trials, September 2007
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    • Ministry of Health and Welfare. Pharmaceutical Afairs Bureau Notifcation No. 739 and Pharmaceutical Review Division Notifcation No. 672 on Ethnic Factors in the Acceptability of Foreign Clinical Data, august 1998
    • Ministry of Health and Welfare. Pharmaceutical Afairs Bureau Notifcation No.739 and Pharmaceutical Review Division Notifcation No. 672 on Ethnic Factors in the Acceptability of Foreign Clinical Data, august 1998.


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