References
- General Considerations for the Clinical Evaluation of Drugs. FDA Bureau of Drugs, Clinical Guidelines, U.S. Government Printing Office, Dept. of Health, Education and Welfare, Washington, D.C., Pub. HEW(FDA)77–3040 (GPO 017–012–00245–5)
- Cox D. R. Planning Experiments. Wiley, New York 1958
- Rodda B. E., et al. Statistical Issues in Drug Research and Development, K. E. Peace. Marcel Dekker, New York 1990
- Snedecor G. W., Cochran W. G. Statistical Methods, 7th ed. Iowa University Press, Ames, Iowa 1980
- Cochran W. G., Cox G. M. Experimental Designs, 2nd ed. Wiley, New York 1957
- Brown B. W., Jr. Biometrics 1980; 36: 69
- Grizzle J. E. Biometrics 1965; 21: 467, 30, 727, 1974
- Westlake W J. Statistical Issues in Drug Research and Development, K. E. Peace. Marcel Dekker, New York 1990
- SAS Institute, Inc., Cary, North Carolina
- FDA Bioavailability/Bioequivalence Regulations. Fed. Reg. 1977; 42: 1624
- Schuirman D. L. Biometrics, 37: 617, abstract
- Schuirman D. L. J. Pharmacokinet. Biopharm. 1987; 15: 657–680
- Chinchilli V. M. Statistical Issues in Drug Research and Development, K. E. Peace. Marcel Dekker, New York 1990
- Winer B. J. Statistical Principles in Experimental Design, 2nd ed. McGraw-Hill, New York 1971
- Buncher C. R., Tsay J.-Y. Statistics in the Pharmaceutical Industry, 2nd ed. Marcel Dekker, New York 1994
- Statistical Issues in Drug Research and Development, Ch. 7, K. E. Peace. Marcel Dekker, New York 1990
- Phillips K. E. J. Pharmacokinet. Biopharm. 1990; 18: 137
- Diletti E., Hauschke D., Steinijans V. W. Inst. J. Clin. Pharm. Ther. and Tox. 1991; 29(1)1
- Hauck W. H., Anderson S. J. Pharmacokin. and Biopharm. 1994; 22: 551
- Makuch R., Simon R. Cancer Treat. Reports 1978; 62(7)1037
- Davis R., Huang I. Statistics in the Pharmaceutical Industry 2nd ed., C. R. Buncher, J.-Y Tsay. Marcel Dekker, New York 1994
- O'Brien P. C., Fleming T. R. Biometrics 1979; 35: 549
- Summary from “Issues with Interim Analysis in the Pharmaceutical Industry”. The PMA Biostatistics and Medical Ad Hoc Committee on Interim Analysis. January, 1990
- Berry D. A. Statistical Methodology in the Pharmaceutical Sciences. Marcel Dekker, New York 1990; 294
- Biopharmaceutical Statistics for Drug Development, Peace, Ch. 11. Marcel Dekker, New York 1988
- Jones G., Kenward M. G. Design and Analysis of Cross-over Trials. Chapman and Hill, London 1989
- Chow S.-C., Liu J.-P. Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker, New York 1992; 280
- Sankoh A. J. Drug Inf. J. 1995; 29: 729