BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

133 related articles for article (PubMed ID: 34787814)

  • 1. 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]  

  • 2. Stakeholders' recommendations for revising Good Clinical Practice.
    Corneli A; Forrest A; Swezey T; Lin L; Tenaerts P
    Contemp Clin Trials Commun; 2021 Jun; 22():100776. PubMed ID: 33997463
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Stakeholders' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).
    Dombeck C; Swezey T; Forrest A; Tenaerts P; Corneli A
    Contemp Clin Trials Commun; 2022 Oct; 29():100983. PubMed ID: 36111176
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates.
    Bechtel J; Chuck T; Forrest A; Hildebrand C; Panhuis J; Pattee SR; Comic-Savic S; Swezey T
    Contemp Clin Trials; 2020 Feb; 89():105918. PubMed ID: 31881391
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study.
    De Sutter E; Borry P; Huys I; Barbier L
    BMC Health Serv Res; 2023 Feb; 23(1):181. PubMed ID: 36810088
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The Investigators' Brochure: a comparison of the draft international conference on harmonisation guideline with current Food and Drug Administration requirements.
    Cocchetto DM
    Qual Assur; 1995 Dec; 4(4):240-6. PubMed ID: 8890349
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The Renovation of Good Clinical Practice: A Framework for Key Components of ICH E8.
    Whitehead M; Suprin M; Mistree T; Kearns MM; Marini G; Goffe C; Pillwein M; Abdul-Shukkoor V
    Ther Innov Regul Sci; 2024 Mar; 58(2):303-310. PubMed ID: 38038888
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. 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]  

  • 11. 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]  

  • 12. [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]  

  • 13. [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]  

  • 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. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).
    Russ H; Busta S; Jost B; Bethke TD
    Ger Med Sci; 2015; 13():Doc02. PubMed ID: 25698912
    [TBL] [Abstract][Full Text] [Related]  

  • 16. International Council for Harmonisation E6(R2) addendum: Challenges of implementation.
    Bhatt A
    Perspect Clin Res; 2017; 8(4):162-166. PubMed ID: 29109932
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan.
    Rokuda M; Matsumaru N; Tsukamoto K
    Clin Ther; 2018 Feb; 40(2):284-295. PubMed ID: 29361305
    [TBL] [Abstract][Full Text] [Related]  

  • 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; 25(3):287-94. PubMed ID: 9492818
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The future of Cochrane Neonatal.
    Soll RF; Ovelman C; McGuire W
    Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.
    Hata T; Nakamura K; Yonemori K; Noguchi E; Watanabe M; Sohn J; Lu YS; Yap YS; Tamura K; Fujiwara Y
    Clin Transl Sci; 2021 May; 14(3):1015-1025. PubMed ID: 33382914
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.