-
1
-
-
84877791791
-
-
International Conference on Harmonization (ICH) E9 Guideline., International Conference on Harmonization, 1998. Available from: (20 August 2007).
-
International Conference on Harmonization (ICH) E9 Guideline. Statistical Principles for Clinical Trials. International Conference on Harmonization, 1998. Available from: http://www.fda.gov/cder/guidance/ICH_E9-fnl.pdf (20 August 2007).
-
Statistical Principles for Clinical Trials.
-
-
-
2
-
-
84877834985
-
-
International Conference on Harmonization (ICH) E10 Guideline. International Conference on Harmonization, 2001. Available from: (20 August 2007).
-
International Conference on Harmonization (ICH) E10 Guideline. Choice of Control Groups in Clinical Trials. International Conference on Harmonization, 2001. Available from: http://www.fda.gov/cder/guidance/4155fnl.pdf (20 August 2007).
-
Choice of Control Groups in Clinical Trials.
-
-
-
3
-
-
0027165431
-
A specification of treatment difference in the design of clinical trials with active controls.
-
Ng T-H. A specification of treatment difference in the design of clinical trials with active controls. Drug Information Journal 1993; 27:705-719.
-
(1993)
Drug Information Journal
, vol.27
, pp. 705-719
-
-
Ng, T.-H.1
-
4
-
-
0035739849
-
Choice of delta in equivalence testing.
-
Ng T-H. Choice of delta in equivalence testing. Drug Information Journal 2001; 35:1517-1527.
-
(2001)
Drug Information Journal
, vol.35
, pp. 1517-1527
-
-
Ng, T.-H.1
-
5
-
-
84877822524
-
-
Committee for Proprietary Medicinal Products (CPMP). Points to consider on the choice of non-inferiority margin (Draft). CPMP /EWP/2158/99 Committee for Proprietary Medicinal Products (CPMP)
-
Committee for Proprietary Medicinal Products (CPMP). Points to consider on the choice of non-inferiority margin (Draft). CPMP /EWP/2158/99, Committee for Proprietary Medicinal Products (CPMP), 2004.
-
(2004)
-
-
-
6
-
-
85054767540
-
Comments regarding CPMP|EWP|2158|99 draft: points to consider on the choice of non-inferiority margin.
-
June
-
Seldrup J. Comments regarding CPMP|EWP|2158|99 draft: points to consider on the choice of non-inferiority margin. International Society for Clinical Biostatistics News, June 2004.
-
(2004)
International Society for Clinical Biostatistics News
-
-
Seldrup, J.1
-
7
-
-
84877835788
-
-
European Medicines Agency (EMEA). Committee for medicinal products for human use (CHMP). Guideline on the choice of the non-inferiority margin. European Medicines Agency (EMEA)
-
European Medicines Agency (EMEA). Committee for medicinal products for human use (CHMP). Guideline on the choice of the non-inferiority margin. EMEA|CPMP|EWP|2158|99, European Medicines Agency (EMEA), 2005.
-
(2005)
EMEA|CPMP|EWP|2158|99
-
-
-
8
-
-
0002306453
-
Statistical review experiences in equivalence testing at FDA/CBER.
-
American Statistical Association: Alexandria, VA
-
Gupta G, Hsu H, Ng T-H, Tiwari T, Wang C. Statistical review experiences in equivalence testing at FDA/CBER. Proceedings of the Biopharmaceutical Section. American Statistical Association: Alexandria, VA, 1999; 220-223.
-
(1999)
Proceedings of the Biopharmaceutical Section.
, pp. 220-223
-
-
Gupta, G.1
Hsu, H.2
Ng, T.-H.3
Tiwari, T.4
Wang, C.5
-
9
-
-
0037285074
-
Statistical issues on objectives, designs and analysis of non-inferiority test active controlled clinical trials.
-
Tsong Y, Wang S-J, Hung H-MJ, Cui L. Statistical issues on objectives, designs and analysis of non-inferiority test active controlled clinical trials. Journal of Biopharmaceutical Statistics 2003; 13:29-41.
-
(2003)
Journal of Biopharmaceutical Statistics
, vol.13
, pp. 29-41
-
-
Tsong, Y.1
Wang, S.-J.2
Hung, H.-M.J.3
Cui, L.4
-
10
-
-
15244357900
-
A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials.
-
Hung H-MJ, Wang S-J, O'Neill RT. A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials. Biometrical Journal 2005; 47:28-36.
-
(2005)
Biometrical Journal
, vol.47
, pp. 28-36
-
-
Hung, H.-M.J.1
Wang, S.-J.2
O'Neill, R.T.3
-
11
-
-
0033004225
-
Some issues in the design and analysis of equivalence trials.
-
Hauck WW, Anderson S. Some issues in the design and analysis of equivalence trials. Drug Information Journal 1999; 33:109-118.
-
(1999)
Drug Information Journal
, vol.33
, pp. 109-118
-
-
Hauck, W.W.1
Anderson, S.2
-
12
-
-
0037383672
-
Assessment of treatment efficacy in non-inferiority trials.
-
Wang S-J, Hung H-MJ. Assessment of treatment efficacy in non-inferiority trials. Controlled Clinical Trials 2003; 24:147-155.
-
(2003)
Controlled Clinical Trials
, vol.24
, pp. 147-155
-
-
Wang, S.-J.1
Hung, H.-M.J.2
-
13
-
-
0023615056
-
A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.
-
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal ofPharmacokinetics and Biopharmaceutic 1987; 15:657-680.
-
(1987)
Journal ofPharmacokinetics and Biopharmaceutic
, vol.15
, pp. 657-680
-
-
Schuirmann, D.J.1
-
14
-
-
0037472909
-
Design and analysis of non-inferiority mortality trials in oncology.
-
Rothmann M, Li N, Chen G, Chi GY-H, Temple R, Tsou H-H. Design and analysis of non-inferiority mortality trials in oncology. Statistics in Medicine 2003; 22:239-264.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 239-264
-
-
Rothmann, M.1
Li, N.2
Chen, G.3
Chi, G.Y.-H.4
Temple, R.5
Tsou, H.-H.6
-
15
-
-
0037472846
-
Non-inferiority trials: the 'at least as good as' criterion.
-
Laster LL, Johnson MF. Non-inferiority trials: the 'at least as good as' criterion. Statistics in Medicine 2003; 22:187-200.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 187-200
-
-
Laster, L.L.1
Johnson, M.F.2
-
16
-
-
0032968433
-
Bayesian design and analysis of active control clinical trials.
-
Simon R. Bayesian design and analysis of active control clinical trials. Biometrics 1999; 55:484-487.
-
(1999)
Biometrics
, vol.55
, pp. 484-487
-
-
Simon, R.1
-
17
-
-
84877834107
-
Noninferiority testing with a given percentage of the control as the noninferiority margin.
-
Biopharmaceutical Section [CD-ROM]. American Statistical Association: Alexandria, VA
-
Hshieh P, Ng T-H. Noninferiority testing with a given percentage of the control as the noninferiority margin. Proceedings of the American Statistical Association, Biopharmaceutical Section [CD-ROM]. American Statistical Association: Alexandria, VA, 2007; 1550-1551.
-
(2007)
Proceedings of the American Statistical Association
, pp. 1550-1551
-
-
Hshieh, P.1
Ng, T.-H.2
-
18
-
-
15244359936
-
Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes.
-
Wellek S. Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes. Biometrical Journal 2005; 47:48-61.
-
(2005)
Biometrical Journal
, vol.47
, pp. 48-61
-
-
Wellek, S.1
-
19
-
-
0037445366
-
Therapeutic equivalence: fallacies and falsification.
-
Garret AD. Therapeutic equivalence: fallacies and falsification. Statistics in Medicine 2003; 22:741-762.
-
(2003)
Statistics in Medicine
, vol.22
, pp. 741-762
-
-
Garret, A.D.1
-
21
-
-
0031866924
-
On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints.
-
Tu D. On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints. Journal of Biopharmaceutical Statistics 1998; 8:263-282.
-
(1998)
Journal of Biopharmaceutical Statistics
, vol.8
, pp. 263-282
-
-
Tu, D.1
-
22
-
-
0347807759
-
Consensus and controversy in pharmaceutical statistics (with Discussion).
-
Senn S. Consensus and controversy in pharmaceutical statistics (with Discussion). Journal of the Royal Statistical Society, Series D 2000; 49:135-176.
-
(2000)
Journal of the Royal Statistical Society, Series D
, vol.49
, pp. 135-176
-
-
Senn, S.1
|