메뉴 건너뛰기




Volumn 125, Issue SUPPL. 1, 2005, Pages 72-76

Methodological recommendations of the Regulatory Agencies;Recomendaciones metodológicas de las agencias reguladoras

Author keywords

Clinical trials; Methodological issues; Regulatory guidelines; Statistical issues

Indexed keywords

ARTICLE; CLINICAL TRIAL; HEALTH CARE PERSONNEL; INTERNET; MEDICAL LITERATURE; MEDICAL RESEARCH; PRACTICE GUIDELINE; PUBLICATION;

EID: 34547725155     PISSN: 00257753     EISSN: 15788989     Source Type: Journal    
DOI: 10.1016/s0025-7753(05)72213-2     Document Type: Article
Times cited : (4)

References (14)
  • 1
    • 34547737925 scopus 로고
    • ICH Harmonised Tripartite Guideline Topic E3
    • International Conference on Harmonization ICH, November
    • International Conference on Harmonization (ICH). ICH Harmonised Tripartite Guideline Topic E3: Structure and Content of Clinical Study Reports. November, 1995.
    • (1995) Structure and Content of Clinical Study Reports
  • 4
    • 34547767533 scopus 로고    scopus 로고
    • International Conference on Harmonization ICH, Choice of Control Group and Related Issues in Clinical Trials. July
    • International Conference on Harmonization (ICH). ICH Harmonised Tripartite Guideline Topic E10: Choice of Control Group and Related Issues in Clinical Trials. July, 2000.
    • (2000) ICH Harmonised Tripartite Guideline Topic
  • 5
    • 34547751839 scopus 로고    scopus 로고
    • CPMP/EWP/482/99 Final. Points to consider on switching between superiority and non-inferiority
    • Committee for Proprietary Medicinal Products CPMP, July
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/482/99 Final. Points to consider on switching between superiority and non-inferiority. London: European Medicines Agency; July, 2000.
    • (2000) London: European Medicines Agency
  • 6
    • 34547784472 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2330/99 Final. Points to Consider on Application with 1.) Meta-analyses and 2.) One Pivotal study. London: European Agency for the Evaluation of Medicinal Product; May, 2001.
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2330/99 Final. Points to Consider on Application with 1.) Meta-analyses and 2.) One Pivotal study. London: European Agency for the Evaluation of Medicinal Product; May, 2001.
  • 7
    • 34547740028 scopus 로고    scopus 로고
    • CPMP/EWP/1776/99 Final. Points to Consider on Missing Data. London: European Agency for the Evaluation of Medicinal Product
    • Committee for Proprietary Medicinal Products CPMP, November
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/1776/99 Final. Points to Consider on Missing Data. London: European Agency for the Evaluation of Medicinal Product; November, 2001.
    • (2001)
  • 9
    • 34547777342 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2863/99 Final. Points to Consider on Adjustment for baseline Covariates. London: European Agency for the Evaluation of Medicinal Product; May, 2003.
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2863/99 Final. Points to Consider on Adjustment for baseline Covariates. London: European Agency for the Evaluation of Medicinal Product; May, 2003.
  • 10
    • 34547756337 scopus 로고    scopus 로고
    • EMEA/CPMP/EWP/2158/ 99 Final. Guideline on the choice of the non-inferiority margin
    • Committee for Proprietary Medicinal Products CPMP, July 27
    • Committee for Proprietary Medicinal Products (CPMP). EMEA/CPMP/EWP/2158/ 99 Final. Guideline on the choice of the non-inferiority margin. London: European Medicines Agency; July 27, 2005.
    • (2005) London: European Medicines Agency
  • 11
    • 34547739537 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP). CHMP/EWP/83561/2005. Guideline on Clinical Trials on Small Populations. London: European Agency for the Evaluation of Medicinal Product; March, 2005.
    • Committee for Medicinal Products for Human Use (CHMP). CHMP/EWP/83561/2005. Guideline on Clinical Trials on Small Populations. London: European Agency for the Evaluation of Medicinal Product; March, 2005.
  • 12
    • 34547753982 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2459/02. Concept Paper on the Development of a Committee for Propietary Medicinal Products (CPMP) Points to Consider on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan. London: European Agency for the Evaluation of Medicinal Product; July, 2002.
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/2459/02. Concept Paper on the Development of a Committee for Propietary Medicinal Products (CPMP) Points to Consider on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan. London: European Agency for the Evaluation of Medicinal Product; July, 2002.
  • 13
    • 34547775752 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP). CHMP/EWP/5872/03. Guideline on Data Monitoring Committees. London: European Agency for the Evaluation of Medicinal Product; July, 2005.
    • Committee for Medicinal Products for Human Use (CHMP). CHMP/EWP/5872/03. Guideline on Data Monitoring Committees. London: European Agency for the Evaluation of Medicinal Product; July, 2005.
  • 14
    • 34547808128 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/139391/04 Draft. Reflection Paper on the regulatory guidance for the use of Health-Related Quality of Life (HRQL) measures in the evaluation of medicinal products. London: European Agency for the Evaluation of Medicinal Product; November, 2004.
    • Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/139391/04 Draft. Reflection Paper on the regulatory guidance for the use of Health-Related Quality of Life (HRQL) measures in the evaluation of medicinal products. London: European Agency for the Evaluation of Medicinal Product; November, 2004.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.