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 *

173 related articles for article (PubMed ID: 22164689)

  • 1. [Impact of the last 15 years: from PMDEC to PMDA --looking back at the first stage of the PMDEC].
    Morimoto K; Fujiwara Y; Kawahara A
    Yakushigaku Zasshi; 2011; 46(1):38-50. PubMed ID: 22164689
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [Review process of new oncology drug application in Japan--role of MD reviewer].
    Fujiwara Y
    Gan To Kagaku Ryoho; 1999 Jan; 26(2 Suppl):196-203. PubMed ID: 9987519
    [TBL] [Abstract][Full Text] [Related]  

  • 3. [Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].
    Morimoto K; Kawasaki S; Yoshida Y
    Yakushigaku Zasshi; 2015; 50(1):64-77. PubMed ID: 26427100
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).
    Fujiwara Y; Kobayashi K
    Crit Rev Oncol Hematol; 2002 May; 42(2):145-55. PubMed ID: 12007972
    [TBL] [Abstract][Full Text] [Related]  

  • 5. [Doctor-initiated clinical trials and the revised pharmaceutical affairs law].
    Takano T; Saijo N
    Gan To Kagaku Ryoho; 2003 Oct; 30(10):1391-7. PubMed ID: 14584270
    [TBL] [Abstract][Full Text] [Related]  

  • 6. MD reviewers' role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center).
    Fujiwara Y
    Jpn J Clin Oncol; 1998 Nov; 28(11):653-6. PubMed ID: 9861230
    [No Abstract]   [Full Text] [Related]  

  • 7. What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI.
    Yoshida S; Matsui R; Kikuchi C
    Ther Innov Regul Sci; 2018 Nov; 52(6):724-730. PubMed ID: 29714572
    [TBL] [Abstract][Full Text] [Related]  

  • 8. [Regulatory authorities expect innovative drug delivery systems (DDS)].
    Mori K
    Yakugaku Zasshi; 2013; 133(1):73-80. PubMed ID: 23292023
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
    Azuma K; Yamanaka S
    Regen Ther; 2016 Jun; 4():36-47. PubMed ID: 31245486
    [TBL] [Abstract][Full Text] [Related]  

  • 10. [In order to perform clinical trials efficiently in Japan--important issues in medical institutions raised by the GCP on-site review].
    Akiyama T; Furuta M; Yamada H
    Nihon Kokyuki Gakkai Zasshi; 2006 Aug; 44(8):541-9. PubMed ID: 16972610
    [TBL] [Abstract][Full Text] [Related]  

  • 11. [Development and evaluation of new drugs and medical devices in Japan--standpoint of regulatory agency].
    Maruyama H; Kondo T
    Brain Nerve; 2010 Mar; 62(3):263-8. PubMed ID: 20297731
    [TBL] [Abstract][Full Text] [Related]  

  • 12. [Performing clinical trials efficiently in Japan--independent clinical trials and GCP].
    Kanai M; Suzuki-Nishimura T
    Nihon Kokyuki Gakkai Zasshi; 2007 Jun; 45(6):449-54. PubMed ID: 17644939
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [The Pharmaceuticals and Medical Devices Agency's Approach to Facilitate Risk Communication and Its Challenges].
    Kondo E; Torii M; Oba I; Okamoto M
    Yakugaku Zasshi; 2018; 138(3):307-314. PubMed ID: 29503421
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Regional Differences During the ICH Regulatory Consultation Process Between the EU, US, and Japan.
    Torqui A; Macau AM
    Ther Innov Regul Sci; 2018 Jul; 52(4):438-441. PubMed ID: 29714552
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [Pharmaceutical agents and medical devices--similar but different].
    Inoue T
    Masui; 2012 Dec; 61(12):1311. PubMed ID: 23362765
    [No Abstract]   [Full Text] [Related]  

  • 16. 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]  

  • 17. [Contribution of pharmacology for new drug application in Japan].
    Suzuki-Nishimura T; Toyoshima S; Uyama Y; Yamada H; Hosoki R; Fujimori K; Nagao T
    Nihon Yakurigaku Zasshi; 2002 Sep; 120(3):187-94. PubMed ID: 12271514
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [70 years of the State Institute for Drug Control].
    Drábek P; Hanzlícek Z
    Cesk Farm; 1988 Sep; 37(7):331-5. PubMed ID: 3058327
    [No Abstract]   [Full Text] [Related]  

  • 19. New Japanese Regulatory Frameworks for Clinical Research and Marketing Authorization of Gene Therapy and Cellular Therapy Products.
    Nagai S; Ozawa K
    Curr Gene Ther; 2017; 17(1):17-28. PubMed ID: 28382858
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Analysis of safety reporting requirements during medical device clinical trials in Japan.
    Azuma K; Iseki H
    J Artif Organs; 2013 Jun; 16(2):234-41. PubMed ID: 23412831
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.