Towards a practical strategy for assessing individual bioequivalence

Journal of Pharmacokinetics and Biopharmaceutics

Volumn 24, Issue 1, 1996, Pages 133-149

  Schall, Robert ^a   Williams, Roger L ^b  

^a UNIVERSITY OF THE FREE STATE   (South Africa)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

bootstrap; individual bioequivalence; moment based criteria; population bioequivalence; probability based criteria; scaled criteria; unscaled criteria

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DATA ANALYSIS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG SOLUTION; METHODOLOGY; NONHUMAN; POPULATION RESEARCH; PRIORITY JOURNAL;

BIOLOGICAL AVAILABILITY; MODELS, BIOLOGICAL; PROBABILITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030011261     PISSN: 0090466X     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF02353513     Document Type: Article

References (16)

1. Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design, Guidance, Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration (revision date: 1 July 1992).
2. Investigation of bioavailability and bioequivalence. In The Rules Governing Medicinal Products in the European Community, Vol. 2, Addendum No. 2, Office for Official Publications of the European Communities, Luxemburg, May 1992, pp. 149-168.
3. S. Hwang, P. B. Huber, M. Hesney and K. C. Kwan. Bioequivalence and interchangeability (letter). J. Pharma. Sci. 67:IV (1978).
4. S. Anderson and W. W. Hauck. Consideration of individual bioequivalence. J. Pharmacokin. Biopharma. 18:259-273 (1990).
5. G. Ekbohm and H. Melander. On Variation, Bioequivalence and Interchangeability, Report 14, Department of Statistics, Swedish University of Agricultural Science, 1990.
6. L. B. Sheiner. Bioequivalence revisited. Statist. Med. 11:1777-1788 (1992).
7. R. Schall and H. G. Luus. On population and individual bioequivalence. Statis. Med. 12:1109-1124 (1993).
8. L. Endrenyi. A procedure for the assessment of individual bioequivalence. In K. K. Midha and H. H. Blume (eds.), Bio-International. Bioavailability, Bioequivalence and Pharmacokinetics, Medpharm, Stuttgart, 1993, pp. 141-146.
9. D. J. Holder and F. Hsuan. Moment-based criteria for determining bioequivalence. Biometrika 80:835-846 (1993).
10. J. D. Esinhart and V. M. Chinchilli. Extension to the use of tolerance intervals for the assessment of individual bioequivalence. J. Biopharm. Statist. 4:39-52 (1994).
11. R. Schall. Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics 51:615-626 (1995).
12. W. W. Hauck and S. Anderson. Measuring switchability and prescribability: when is average bioequivalence sufficient? J. Pharmacokin. Biopharma. 22:551-564 (1994).
13. R. Schall. A unified view of individual, population, and average bioequivalence. In H. H. Blume and K. K. Midha (eds.), Bio-International 2. Bioavailability, Bioequivalence and Pharmacokinetic Studies, Medpharm, Stuttgart, 1995, pp. 91-106.
14. W. J. Westlake. Bioavailability and bioequivalence of pharmaceutical formulations. In K. E. Peace (ed.), Pharmaceutical Statistics for Drug Development, Marcel Dekker, New York, 1988, pp. 329-352.
15. G. Ekbohm and H. Melander. The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics 45:1249-1254 (1989).
16. L. Z. Benet. Bioavailability and bioequivalence: Definitions and difficulties in acceptance criteria. In K. K. Midha and H. H. Blume (eds.), Bio-International. Bioavailability, Bioequivalence and Pharmacokinetics, Medpharm, Stuttgart, 1993, pp. 27-35.