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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.
International Conference on Harmonization ICH, Trials. February
International Conference on Harmonization (ICH). ICH Harmonised Tripartite Guideline Topic E9: Statistical Principles for Clinical Trials. February, 1998.
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.
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.
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
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)
8
34547808803
Committee for Proprietary Medicinal Products CPMP, September
Committee for Proprietary Medicinal Products (CPMP). CPMP/EWP/908/99 Final. CPMP Points to Consider on Multiplicity issues in Clinical Trials. London: European Agency for the Evaluation of Medicinal Product; September, 2002.
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
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.
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.
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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
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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
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.