-
1
-
-
0029147608
-
Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Purposes
-
CPMP Working Party on Efficacy of Medicinal Products
-
CPMP Working Party on Efficacy of Medicinal Products. 1995. Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Purposes. Statistics in Medicine, 14: 1659 - 1682.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 1659-1682
-
-
-
2
-
-
33748675101
-
A Guideline on Summary of Product Characteristics
-
European Commission, Available at
-
European Commission. 2009. " A Guideline on Summary of Product Characteristics ". Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000267.jsp&mid=WC0b01ac05800b378b
-
(2009)
-
-
-
3
-
-
0003419289
-
Note for Guidance on Good Clinical Practice
-
European Medicines Agency, ICH Topic E6 (R1). Available at
-
European Medicines Agency. 1996. " Note for Guidance on Good Clinical Practice ". ICH Topic E6 (R1). Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
-
(1996)
-
-
-
4
-
-
0003884757
-
Points to Consider on Application With 1. Meta-analyses; 2. One Pivotal Study
-
European Medicines Agency, CPMP/EWP/2330/99. Available at
-
European Medicines Agency. 2001. " Points to Consider on Application With 1. Meta-analyses; 2. One Pivotal Study ". CPMP/EWP/2330/99. Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
-
(2001)
-
-
-
5
-
-
0141918127
-
Points to Consider on Multiplicity Issues in Clinical Trials
-
European Medicines Agency, CPMP/EWP/908/99, Available at
-
European Medicines Agency. 2002. " Points to Consider on Multiplicity Issues in Clinical Trials ". CPMP/EWP/908/99, Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
-
(2002)
-
-
-
6
-
-
84884301361
-
Questions and Answers, Ethnic Factors in the Acceptability of Foreign Clinical Data
-
European Medicines Agency, ICH Topic E5 (R1). Available at
-
European Medicines Agency. 2003. " Questions and Answers, Ethnic Factors in the Acceptability of Foreign Clinical Data ". ICH Topic E5 (R1). Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
-
(2003)
-
-
-
7
-
-
70449645866
-
Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned With an Adaptive Design
-
European Medicines Agency, CHMP/EWP/2459/02. Available at
-
European Medicines Agency. 2007. " Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned With an Adaptive Design ". CHMP/EWP/2459/02. Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
-
(2007)
-
-
-
8
-
-
84884305509
-
Missing Data in Confirmatory Clinical Trials
-
European Medicines Agency, CPMP/EWP/1776/99 Rev.1. Available at
-
European Medicines Agency. 2010. " Missing Data in Confirmatory Clinical Trials ". CPMP/EWP/1776/99 Rev.1. Available at http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
-
(2010)
-
-
-
9
-
-
0033566769
-
Statistical Principles for Clinical Trials: ICH Harmonised Tripartite Guideline
-
ICH E9 Expert Working Group
-
ICH E9 Expert Working Group. 1999. Statistical Principles for Clinical Trials: ICH Harmonised Tripartite Guideline. Statistics in Medicine, 18: 1905 - 1942.
-
(1999)
Statistics in Medicine
, vol.18
, pp. 1905-1942
-
-
-
10
-
-
40749136296
-
Editorial: 10 Years of E9
-
Lewis, J. 2008. Editorial: 10 Years of E9. Pharmaceutical Statistics, 7: 1 - 3.
-
(2008)
Pharmaceutical Statistics
, vol.7
, pp. 1-3
-
-
Lewis, J.1
-
11
-
-
0028840157
-
Statistical Issues in the Regulation of Medicines
-
Lewis, J. A. 1995. Statistical Issues in the Regulation of Medicines. Statistics in Medicine, 14: 127 - 136.
-
(1995)
Statistics in Medicine
, vol.14
, pp. 127-136
-
-
Lewis, J.A.1
-
12
-
-
0037108238
-
The European Regulatory Experience
-
Lewis, J. A. 2002. The European Regulatory Experience. Statistics in Medicine, 21: 2931 - 2938.
-
(2002)
Statistics in Medicine
, vol.21
, pp. 2931-2938
-
-
Lewis, J.A.1
-
13
-
-
0035884461
-
The Impact of the Guideline Entitled Statistical Principles for Clinical Trials (ICH E9)
-
Lewis, J., Louv, W., Rockhold, F. and Sato, T. 2001. The Impact of the Guideline Entitled Statistical Principles for Clinical Trials (ICH E9). Statistics in Medicine, 20: 2549 - 2560.
-
(2001)
Statistics in Medicine
, vol.20
, pp. 2549-2560
-
-
Lewis, J.1
Louv, W.2
Rockhold, F.3
Sato, T.4
-
14
-
-
0003616470
-
Guideline for the Statistical Analysis of Clinical Trials
-
Ministry of Health and Welfare, Tokyo, Japan, Tokyo,: MHW Pharmaceutical Affairs Bureau, (in Japanese)
-
Ministry of Health and Welfare. 1992. " Guideline for the Statistical Analysis of Clinical Trials ". Tokyo, Japan: MHW Pharmaceutical Affairs Bureau. (in Japanese)
-
(1992)
-
-
-
15
-
-
79952576381
-
The Prevention and Treatment of Missing Data in Clinical Trials
-
Panel on Handling Missing Data in Clinical Trials; US National Research Council, Washington, DC, Washington, DC,: The National Academies Press, Available at
-
Panel on Handling Missing Data in Clinical Trials; US National Research Council. 2010. " The Prevention and Treatment of Missing Data in Clinical Trials ". Washington, DC: The National Academies Press. Available at http://www.nap.edu/catalog.php?record_id=12955#orgs
-
(2010)
-
-
|