These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

126 related articles for article (PubMed ID: 21814198)

  • 1. 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; 90(3):432-41. PubMed ID: 21814198
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Different contributions of internal reviewers and external experts to labelling decisions on therapeutic indications in new drug reviews in Japan.
    Yokota M; Kusama M; Matsuki N; Ono S
    J Clin Pharm Ther; 2013 Dec; 38(6):456-61. PubMed ID: 23848321
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Clinical development and review times for new drugs in Japan: associated factors.
    Ishibashi T; Yasuda K; Kusama M; Sugiyama Y; Ono S
    Clin Pharmacol Ther; 2010 Oct; 88(4):487-91. PubMed ID: 20739921
    [TBL] [Abstract][Full Text] [Related]  

  • 4. New drug approval times and clinical evidence in Japan.
    Ono S; Yoshioka C; Asaka O; Tamura K; Shibata T; Saito K
    Contemp Clin Trials; 2005 Dec; 26(6):660-72. PubMed ID: 16122988
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Therapeutic indications in oncology: emerging features and regulatory dynamics.
    Tafuri G; Leufkens HG; Laing R; Trotta F
    Eur J Cancer; 2010 Feb; 46(3):471-5. PubMed ID: 20056536
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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; 87(2):212-8. PubMed ID: 19940847
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999.
    Cross J; Lee H; Westelinck A; Nelson J; Grudzinskas C; Peck C
    Pharmacoepidemiol Drug Saf; 2002 Sep; 11(6):439-46. PubMed ID: 12426927
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Analysis of regulatory review times of new drugs in Japan: association with characteristics of new drug applications, regulatory agency, and pharmaceutical companies.
    Ishibashi T; Kusama M; Sugiyama Y; Ono S
    J Clin Pharm Ther; 2012 Dec; 37(6):657-63. PubMed ID: 22734557
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Drug-review deadlines and safety problems.
    Carpenter D; Zucker EJ; Avorn J
    N Engl J Med; 2008 Mar; 358(13):1354-61. PubMed ID: 18367738
    [TBL] [Abstract][Full Text] [Related]  

  • 10. What's next after 50 years of psychiatric drug development: an FDA perspective.
    Laughren TP
    J Clin Psychiatry; 2010 Sep; 71(9):1196-204. PubMed ID: 20923624
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
    Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
    J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Characteristics of and trends in the late-stage biopharmaceutical pipeline.
    Nagle PC; Nicita CA; Gerdes LA; Schmeichel CJ
    Am J Manag Care; 2008 Apr; 14(4):226-9. PubMed ID: 18402515
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Analysis of the success rates of new drug development in Japan and the lag behind the US.
    Hirai Y; Yamanaka Y; Kusama M; Ishibashi T; Sugiyama Y; Ono S
    Health Policy; 2012 Mar; 104(3):241-6. PubMed ID: 22172246
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Canadian and US drug approval times and safety considerations.
    Rawson NS; Kaitin KI
    Ann Pharmacother; 2003 Oct; 37(10):1403-8. PubMed ID: 14519031
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Analysis of 10 years drug lifecycle management (LCM) activities in the Japanese market.
    Hashitera Y; Saotome C; Yamamoto H
    Drug Discov Today; 2013 Nov; 18(21-22):1109-16. PubMed ID: 23856327
    [TBL] [Abstract][Full Text] [Related]  

  • 16. [Improvement of package insert CYP information for prescription drugs marketed in Japan].
    Hirata-Koizumi M; Saito M; Urano T; Miyake S; Hasegawa R
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2005; (123):12-8. PubMed ID: 16541745
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006.
    Bhattaram VA; Bonapace C; Chilukuri DM; Duan JZ; Garnett C; Gobburu JV; Jang SH; Kenna L; Lesko LJ; Madabushi R; Men Y; Powell JR; Qiu W; Ramchandani RP; Tornoe CW; Wang Y; Zheng JJ
    Clin Pharmacol Ther; 2007 Feb; 81(2):213-21. PubMed ID: 17259946
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Differences between Japan and the United States in dosages of drugs recently approved in Japan.
    Nakashima K; Narukawa M; Kanazu Y; Takeuchi M
    J Clin Pharmacol; 2011 Apr; 51(4):549-60. PubMed ID: 20628171
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
    Wharton GT; Murphy MD; Avant D; Goldsmith JV; Chai G; Rodriguez WJ; Eisenstein EL
    Pediatrics; 2014 Aug; 134(2):e512-8. PubMed ID: 25022732
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Investigational drug tracking: phases I-III and NDA submissions--Part II.
    Grant KL
    Hosp Pharm; 1994 Oct; 29(10):900, 902-4, 906-11 passim. PubMed ID: 10137850
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.