Bioequivalence: An overview of statistical concepts

Indian Journal of Pharmacology

Volumn 36, Issue 4, 2004, Pages 209-216

  Rani, Shubha ^a   Pargal, A ^b  

^a BV Patel   (India)

^b Hindustan Lever Limited   (India)

Author keywords

Bioequivalence study designs; Comparative bioavailability; Statistical analysis

Indexed keywords

DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DESIGN; ERROR; HUMAN; HYPOTHESIS; PARALLEL DESIGN; REVIEW; STANDARD; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS; VARIANCE;

EID: 4444348756     PISSN: 02537613     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (32)

1. Food and Drug Administration (FDA), Guidance for Industry: Statistical approaches to establishing bioequivalence 2001.
2. Canadian Health Protection Branch (HPB), Drugs Directorate Policy: CI standard for comparative bioavailability 1991.
3. Committee for Proprietary Medicinal Products (CPMP), Working Party on Efficacy of Medicinal Products. Note for guidance: Investigation of bioavailability and bioequivalence 1998.
4. Catz B, Ginsburg E, Salenger S. Clinically inactive Thyroid USP. A preliminary report. New Engl J Med 1962;266:136-7.
5. Braverman LE, Ingbar SH. Anomalous effects of certain preparations of desiccated thyroid on serum protein-based iodine. New Engl J Med 1964;270:439-42.
6. Ramos-Gabatin A, Jacobson JM, Young RL. In vivo comparison of levothyroxine preparations. J Am Med Assoc 1982;247:203-5.
7. Whitting B, Rodger J, Summer D. New formulation of digoxin. Lancet 1972;2:922-3.
8. Stewart MJ, Simpson E. New formulation of lanoxin: Expected plasma levels of digoxin. Lancet 1972;2:541.
9. Levy G. Effect of dosage form properties on therapeutic efficacy of tolbutamide tablets. Can Med Assoc J 1964;90:978-9.
10. Lu FC, Rice WB, Mainville CW. A comparative study of some brands of tolbutamide in Canada, part II, pharmaceutical aspects. Can Med Assoc J 1965;92:1166-9.
11. Campagna FA, Cureton G, Mirigian RA, Nelson E. Inactive prednisone tablets, USP XVI. Pharm Technol 1963;52:605-6.
12. Sullivan TJ, Sakmar E, Albert KS, Blair DC, Wagner JG. In vitro and in vivo availability of commercial prednisone tablets. J Pharm Sci 1975;64:1723-5.
13. Albert KS, Sakmar E, Hallmark MR, Weidler DJ, Wagner JG. Bioavailability of diphenylhydantoin. Clin Pharmacol Ther 1974;16:727-35.
14. Gibaldi M, Perrier D. Pharmacokinetics. 2nd Ed. New York: Marcel Dekker 1982.
15. Grizzle JE. The two-period change-over design and its use in clinical trials. Biometrics 1965;21:467-80.
16. Zar JH. Biostatistical Analysis. 2nd Ed. New Jersey: Prentice-Hall, Inc., Englewood Cliffs 1984.
17. Armitage P. Statistical methods in medical research. New York: Wiley and Sons 1973.
18. Cochran WG, Cox GM. Experimental designs. 2nd Ed. New York: Wiley and Sons 1957.
19. Fisher RA. The design of experiments. 8th Ed. New York: Hafner Publishing Company 1966.
20. Food and drug administration (FDA), Division of Biopharmaceutics, Bioavailability protocol guidelines for ANDA and NDA Submission, 1977.
21. Hauck WW, Anderson S. A new statistical procedure for testing equivalence in two-group comparative bioavailability trials. J Pharmacokinet Biopharm 1984; 12:83-91.
22. Schuirmann DJ. A comparison of two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657-80.
23. Westlake WJ. Bioavailability and bioequivalence of pharmaceutical formulations. In: Peace KE, editor. Biopharmaceutical statistics for drug development, 1st Ed. New York: Marcel Dekker 1988. p. 329-52.
24. Westlake WJ. Use of confidence intervals in analysis of comparative bioavailability trials. J Pharm Sci 1972;61:1340-1.
25. Metzler CM. Bioavailability: A problem in bioequivalence. Biometrics 1974;30:309-17.
26. Kirkwood TBL. Bioequivalence testing - A need to rethink. Biometrics 1981;37:589-91.
27. Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics 1976;32:741-4.
28. Westlake WJ. Response to Kirkwood TBL: Bioequivalence testing - A need to rethink. Biometrics 1981;37:589-94.
29. Meeting of generic drug advisory committee to the FDA. Washington 1991.
30. Liu JP, Chow SC. Sample size determination for the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm 1992;20:101-4.
31. Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1991;29:1-8.
32. Hauschke D, Steinijans VW, Diletti E, Burke M. Sample size determination for bioequivalence assessment using a multiplicative model. J Pharmacokinet Biopharm 1992;20:557-61.