Sample sizes for clinical trials with Normal data
Tóm tắt
Từ khóa
Tài liệu tham khảo
ICH E9. Statistical principals for clinical trials. September1998.http://www.fda.gov/cder/guidance/ICH_E9‐fnl.PDF[last accessed 23 October 2003].
Altman DG, 1999, Treatment allocation in controlled trials: why randomize?, British Medical Journal, 318, 1209, 10.1136/bmj.318.7192.1209
Day S, 1998, Encyclopedia of Biostatistics, 410
ICH E3. Structure and content of clinical study reports. July1996.http://www.fda.gov/cder/guidance/iche3.pdf[last accessed 23 October 2003].
HintzJL. PASS 2000 User's Guide. Kaysville 2000.
ElashoffJD. nQuery advisor version 4 user's guide. Los Angeles 2000.
Machin D, 1997, Statistical Tables for the Design of Clinical Studies
CPMP. Points to consider on multiplicity issues in clinical trials. (CPMP/EWP/908/99) 19 September 2002http://www.emea.eu.int/pdfs/human/ewp/090899en.pdf(last accessed 21 October 2003 ).
Neyman J, 1928, On the use and interpretation of test criteria, Biometrika, 20, 175
Neyman J, 1933, On the problem of the most efficient tests of statistical hypotheses, Philosophical Transitions Royal Society (London), 23, 289
Neyman J, 1936, Contributions to the theory of testing hypotheses, Journal Statistical Research Memoirs (University of London), 1, 1
Neyman J, 1936, Sufficient statistics and uniformly most powerful test of statistical hypothesis, Journal Statistical Research Memoirs (University of London), 1, 113
Neyman J, 1938, Contributions to the theory of testing statistical hypotheses, Journal Statistical Research Memoirs (University of London), 2, 25
BrushGG. How to choose the proper sample size vol. 12 The ASQC Basic References in Quality Control Statistical Techniques American Society for Quality Control: Milwaukee WI 1988.
Senn S, 1993, Cross‐over Trials in Clinical Research
Chow SC, 2002, A note on sample size calculations for mean comparisons based on noncentral t‐statistics, Journal of Pharmaceutical Statistics, 12, 441
ICH E10 Choice of control group in clinical trials 2000. May2001http://www.fda.gov/cder/guidance/4155fnl.pdf(last accessed 10 November 2003).
CPMP. Points to consider on switching between superiority and non‐inferiority. (CPMP/EWP/482/99) 17 July 2000.http://www.emea.eu.int/pdfs/human/ewp/048299en.pdf(last accessed 21 October 2003).
CPMP. Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on biostatistical methodological issues arising from recent CPMP discussions on licensing applications: choice of delta. (CPMP/EWP/2158/99) 23 September1999.http://www.emea.eu.int/ pdfs/human/ewp/215899en.pdf(last accessed 21 October 2003).
Diletti E, 1991, Sample size determination form bioequivalence assessment by means of confidence intervals, International Journal of Clinical Pharmacology, Therapy and Toxicology, 29, 1
FDA. Guidance for industry. Bioavailability and bioequivalence studies for orally administered drug products—general considerations. October2000.http://www.fda.gov/cder/guidance/3615fnl.pdf(last accessed 23 October 2003).
FDA. Statistical approaches to establishing bioequivalence. January2001.http://www.fda.gov/cder/guidance/3616fnl.pdf(last accessed 23 October 2003).
CPMP. Note for guidance on the investigation of bioavailability and bioequivalence. (CPMP/EWP/QWP1401/98) 26 July2001.http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf(last accessed 21 October 2003).
FDA. Guidance for industry. Food‐effect bioavailability and fed bioequivalence studies. December2000.http://www.fda.gov/cder/guidance/5194fnl.pdf(last accessed 23 October 03).
CPMP. Note for guidance on the investigation of drug interactions. (CPMP/EWP/560/95) 17 December1997.http://www.emea.eu.int/pdfs/human/ewp/056095en.pdf(last accessed 21 October 2003).
FDA. Guidance for industry. In vivo drug metabolism/drug interaction studies—study design data analysis and recommendations for dosing and labelling. November1999.http://www.fda.gov/cder/guidance/2635fnl.pdf(last accessed 23 October 2003).
FDA. Guidance for industry. Pharmacokinetics in patients with impaired renal function—study design data analysis and impact on dosing and labelling. May1998.http://www.fda.gov/cder/guidance/1449fnl.pdfpdf (last accessed 23 October 2003).
FDA. Guidance for industry. Pharmacokinetics in patients with impaired hepatic function: study design data analysis and impact on dosing and labelling. May2003.http://www.fda.gov/cder/guidance/3625fnl.pdf(last accessed 23 October 2003).
Hauck WW, 1992, Types of bioequivalence and related statistical considerations, International Journal of Clinical Pharmacology, Therapy and Toxicology, 30, 181
Wood J, 1999, Sample‐size calculations for trials in health services research, Journal of Health Services and Research and Policy, 4, 226, 10.1177/135581969900400408
Desu MM, 1990, Sample Size Methodology
CPMP. Points to consider on adjustment for baseline covariates. (CPMP/EWP/2863/99) 23 May2003.http://www.emea.eu.int/pdfs/human/ewp/286399en.pdf(last accessed 21 October 2003).
Diggle PJ, 1996, Analysis of Longitudinal Data