BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

153 related articles for article (PubMed ID: 11067647)

  • 1. Clinical trials and the new good clinical practice guideline in Japan. An economic perspective.
    Ono S; Kodama Y
    Pharmacoeconomics; 2000 Aug; 18(2):125-41. PubMed ID: 11067647
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M; Bertram D
    Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
    [TBL] [Abstract][Full Text] [Related]  

  • 3. [ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives].
    Englev E; Petersen KP
    Ugeskr Laeger; 2003 Apr; 165(16):1659-62. PubMed ID: 12756823
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [Implementation of new Japanese GCP and the quality of clinical trials--from the standpoint of the pharmaceutical industry].
    Ebi O
    Gan To Kagaku Ryoho; 1997 Oct; 24(13):1883-91. PubMed ID: 9350232
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Clinical pharmacologists and drug regulation--future perspective in Japan.
    Hirokawa K
    Br J Clin Pharmacol; 1996 Jul; 42(1):63-71. PubMed ID: 8807146
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle.
    Browne LH; Graham PH
    Clin Trials; 2014 Dec; 11(6):629-34. PubMed ID: 25023199
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [The Nazis, guide of the International Conference of Harmonization and ethics committees].
    Palma-Aguirre JA; Rebollo-Franco DI; Gómez-Delgado A; Villa-Caballero L
    Gac Med Mex; 2003; 139(4):415-22. PubMed ID: 14574765
    [TBL] [Abstract][Full Text] [Related]  

  • 8. [Development of anti-cancer drugs under new renewed GCP--from the viewpoint of drug development company developer].
    Ueno T; Kobayashi T; Inoue K; Yanagi Y; Yamada Y
    Gan To Kagaku Ryoho; 1998 Apr; 25(5):663-70. PubMed ID: 9571963
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study.
    Hurley C; Sinnott C; Clarke M; Kearney P; Racine E; Eustace J; Shiely F
    Trials; 2017 Sep; 18(1):423. PubMed ID: 28893317
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections.
    Ono S; Kodama Y; Nagao T; Toyoshima S
    Control Clin Trials; 2002 Feb; 23(1):29-41. PubMed ID: 11852162
    [TBL] [Abstract][Full Text] [Related]  

  • 11. American Society of Clinical Oncology policy statement: oversight of clinical research.
    American Society of Clinical Oncology
    J Clin Oncol; 2003 Jun; 21(12):2377-86. PubMed ID: 12721281
    [TBL] [Abstract][Full Text] [Related]  

  • 12. [In order to perform clinical trials efficiently in Japan--important issues regarding monitoring by sponsors].
    Kaichi S; Oda T; Goto K; Sato K
    Nihon Kokyuki Gakkai Zasshi; 2007 Nov; 45(11):829-35. PubMed ID: 18051783
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [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]  

  • 14. Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?
    Knaapen M; Ploem MC; Kruijt M; Oudijk MA; van der Graaf R; Bet PM; Bakx R; van Heurn LWE; Gorter RR; van der Lee JH
    Eur J Pediatr; 2020 Aug; 179(8):1205-1211. PubMed ID: 32535715
    [TBL] [Abstract][Full Text] [Related]  

  • 15. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use.
    Int Dig Health Legis; 1997; 48(2):231-4. PubMed ID: 11656783
    [No Abstract]   [Full Text] [Related]  

  • 16. [Experience as a model hospital for new good clinical practice (GCP) regulations].
    Tanaka S
    Gan To Kagaku Ryoho; 1998 Aug; 25(10):1467-73. PubMed ID: 9725036
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Ethical considerations in clinical trials: a critique of the ICH-GCP guideline.
    Kaur S; Choy CY
    Dev World Bioeth; 2014 Apr; 14(1):20-8. PubMed ID: 23170779
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation.
    Nakamura K; Ozawa H; Shibata T; Ushirozawa N; Hata T; Okita N; Fuse N; Sato N; Ikeda K; Hanaoka H; Maruyama T; Wada M; Shimizu S; Kasai H; Yamamoto Y; Sakurai J; Todaka K; Tashiro S; Yamamoto H
    Ther Innov Regul Sci; 2022 Mar; 56(2):220-229. PubMed ID: 34787814
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Is ICH exportable outside the European Union?
    Dent NJ
    Qual Assur; 2000; 8(1):19-31. PubMed ID: 11710304
    [TBL] [Abstract][Full Text] [Related]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 8.