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Pubmed for Handhelds

PUBMED FOR HANDHELDS

Journal Abstract Search

221 related items for PubMed ID: 16122988

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  • 2. Characteriation of clinical data packages using foreign data in new drug applications in Japan.
    Tanaka M, Nagata T.
    Clin Pharmacol Ther; 2008 Sep; 84(3):340-6. PubMed ID: 17786162
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  • 6. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.
    Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.
    AAPS J; 2005 Oct 07; 7(3):E503-12. PubMed ID: 16353928
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  • 8. Delays in new drug applications in Japan and industrial R&D strategies.
    Hirai Y, Kinoshita H, Kusama M, Yasuda K, Sugiyama Y, Ono S.
    Clin Pharmacol Ther; 2010 Feb 07; 87(2):212-8. PubMed ID: 19940847
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  • 11. Analysis of labeling decisions regarding therapeutic indications during new drug application reviews in Japan.
    Yokota M, Kusama M, Sugiyama Y, Ono S.
    Clin Pharmacol Ther; 2011 Sep 07; 90(3):432-41. PubMed ID: 21814198
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  • 14. The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.
    Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P.
    Eur J Clin Pharmacol; 2002 Dec 07; 58(9):573-80. PubMed ID: 12525957
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  • 16. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Jul 10; 73(133):39588-611. PubMed ID: 18850675
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  • 18. [Development of an anticancer drug in Japan based on a new clinical trial system].
    Nakashima H, Nakano S.
    Gan To Kagaku Ryoho; 1998 Feb 10; 25(3):287-94. PubMed ID: 9492818
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