-
1
-
-
84954379510
-
Practical guide to sample size calculations: An Introduction
-
Flight LG, Julious SA,. Practical guide to sample size calculations: an Introduction. Pharmaceutical Statistics, DOI: 10.1002/pst.1709.
-
Pharmaceutical Statistics
-
-
Flight, L.G.1
Julious, S.A.2
-
2
-
-
84954283356
-
-
epiGenesys. A University of Sheffield company. (accessed 07.07.2015)
-
epiGenesys. A University of Sheffield company. Available at: https://www.epigenesys.org.uk/portfolio/sampsize// (accessed 07.07.2015).
-
-
-
-
3
-
-
27544475840
-
-
CHMP. Doc CPMP/EWP/2158/99 January 2006. (accessed 07.07.2015)
-
CHMP. Guideline on the choice of non-inferiority margin. Doc CPMP/EWP/2158/99 January 2006. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003636.pdf (accessed 07.07.2015).
-
Guideline on the Choice of Non-inferiority Margin
-
-
-
5
-
-
4344584922
-
Tutorial in Biostatistics: Sample sizes for clinical trials with Normal Data
-
Julious SA,. Tutorial in Biostatistics: Sample sizes for clinical trials with Normal Data. Statistics in Medicine. 2004; 23: 1921-86.
-
(2004)
Statistics in Medicine
, vol.23
, pp. 1921-1986
-
-
Julious, S.A.1
-
7
-
-
0003828057
-
-
CPMP. (CPMP/EWP/482/99) 27 July 2000. (accessed 07.07.2015)
-
CPMP. Points to consider on switching between superiority and non-inferiority. (CPMP/EWP/482/99) 27 July 2000. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scien-tific-guideline/2009/09/WC500003658.pdf (accessed 07.07.2015).
-
Points to Consider on Switching between Superiority and Non-inferiority
-
-
-
8
-
-
84954283357
-
-
ICH E10 Choice of control group in clinical trials. May 2001. (accessed 07.07.2015)
-
ICH E10 Choice of control group in clinical trials. 2000. May 2001. Available at: http://www.ich.org/fileadmin/ Public\-Web\-Site/ICH-Products/Guidelines/Efficacy/E10/Step4/E10-Guideline.pdf (accessed 07.07.2015).
-
(2000)
-
-
-
9
-
-
0029987569
-
Trials to assess equivalence: The importance of rigorous methods
-
Jones B, Jarvis P, Lewis JA, Ebbutt AF,. Trials to assess equivalence: the importance of rigorous methods. British Medical Journal. 1996; 313: 36-39.
-
(1996)
British Medical Journal
, vol.313
, pp. 36-39
-
-
Jones, B.1
Jarvis, P.2
Lewis, J.A.3
Ebbutt, A.F.4
-
10
-
-
80053561105
-
The ABC of non-inferiority margin setting: An investigation of approaches
-
Julious SA,. The ABC of non-inferiority margin setting: an investigation of approaches. Pharmaceutical Statistics. 2011; 10 (5): 448-53.
-
(2011)
Pharmaceutical Statistics
, vol.10
, Issue.5
, pp. 448-453
-
-
Julious, S.A.1
-
11
-
-
57449091085
-
Issues with indirect comparisons in clinical trials particularly with respect to non-inferiority trials
-
Julious SA, Wang SJ, Issues with indirect comparisons in clinical trials particularly with respect to non-inferiority trials,. Drug Information Journal. 2008; 42 (6): 625-33.
-
(2008)
Drug Information Journal
, vol.42
, Issue.6
, pp. 625-633
-
-
Julious, S.A.1
Wang, S.J.2
-
12
-
-
84954203751
-
-
ICH E9. September 1998. (accessed 07.07.2015)
-
ICH E9. Statistical principals for clinical trials. September 1998. Available at: http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf (accessed 07.07.2015).
-
Statistical Principals for Clinical Trials
-
-
-
14
-
-
84954271587
-
Practical guide to sample size calculations: Superiority trials
-
Flight L, Julious SA,. Practical guide to sample size calculations: superiority trials. Pharmaceutical Statistics, DOI: 10.1002/pst.1718.
-
Pharmaceutical Statistics
-
-
Flight, L.1
Julious, S.A.2
-
15
-
-
0028807804
-
A useful testing strategy in phase III trials: Combined test of superiority and test of equivalence
-
Morikawa T, Yoshida M,. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. Journal of Biopharmaceutical Statistics. 1995; 5 (3): 297-306.
-
(1995)
Journal of Biopharmaceutical Statistics
, vol.5
, Issue.3
, pp. 297-306
-
-
Morikawa, T.1
Yoshida, M.2
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