Partial-area method in bioequivalence assessment: Naproxen

Biopharmaceutics and Drug Disposition

Volumn 18, Issue 2, 1997, Pages 103-116

  Niazi, Sarfaraz K ^a,b   Alam, Syed M ^a   Ahmad, Syed I ^a  

^a UNIVERSITY OF KARACHI   (Pakistan)

^b Gulf Pharmaceutical Industry   (United Arab Emirates)

Author keywords

bioequivalence; naproxen; partial area methods

Indexed keywords

NAPROXEN;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; DRUG RELEASE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; ORAL DRUG ADMINISTRATION;

ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; BAYES THEOREM; CONFIDENCE INTERVALS; EVALUATION STUDIES; HUMANS; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; NAPROXEN; PROBABILITY; REFERENCE VALUES; THERAPEUTIC EQUIVALENCY;

EID: 0031001957     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1099-081X(199703)18:2<103::AID-BDD4>3.0.CO;2-S     Document Type: Article

References (36)

1. V. W. Steinijans, Pharmacokinetic characteristic of controlled release product and their biostatistical analysis. In: Wissenschaft-liche, U. Gundort-Remy and H. Moeller (Eds), Oral controlled release product-therapeutic and biopharmaceutic assessment, Stuttgart, 1989, pp. 99-105.
2. K. Khoo, M. Gibaldi and R. K. Brazzell, Comparison of statistical moment parameters to Cmax and Tmax for detecting difference in in vivo dissolution rates. J. Pharm. Sci., 74, 1340-1342 (1985).
3. A. J. Jackson and M.-L. Chen, Application of moment analysis in assessing rates of absorption for bioequivalency studies. J. Pharm. Sci., 76(1), 6-9 (1987).
4. L. Aarsons, Assessment of rate of absorption in bioequivalence studies. J. Pharm. Sci., 76(10), 853-855 (1987).
5. Mei-Ling Chen, Assessment of rate of absorption in bioequivalence studies. U.S. Food and Drug Administration, Generic Drugs Advisory Committee Meeting, September 1991, Bethesda, MD.
6. A. Rostami-Hodjegan, P. R. Jackson and G. T. Tucker, Sensitivity of indirect metrices for assessing 'rate' in bioequivalence studies - moving the 'goalposts' or changing the 'game'. J. Pharm. Sci., 83(11), 1554-1557 (1994).
7. S. E. Rosenbaum, C. T. Rhodes and C. Bon, Area under the curve estimation in bioequivalence studies. Drug Dev. Ind. Pharm., 16(1), 157-163 (1990).
8. Mei-Ling Chen, An alternative approach for assessment of rate of absorption in bioequivalence studies. Pharm. Res., 9(11), 1380-1385 (1992).
9. A. J. Romero, C. Bon, E. Johnson, S. E. Rosenbaum and C. T. Rhodes, Use and limitations of the truncated area under the curve in bioequivalence testing. Clin. Res. Prac. Drug Reg. Affairs, 8(2), 123-151 (1990).
10. S. Niazi, Volume of distribution as a function of time. J. Pharm. Sci., 65, 1541-1543 (1976).
11. FDA 1 July 1992 Guidelines, Bioequivalence Food and Drug Administration, Division of Bioequivalence, Office of Generic Drugs. Rockville, MD.
12. C. M. Metzler, Bioavailability - a problem in equivalence. Biometrics, 30, 309-317 (1974).
13. C. M. Metzler, Statistical methods for deciding bioequivalence of formulation. Drug Absorption from Sustained Release Formulation, Pergamon, New York, 1988, pp. 217-238.
14. J. O'Quigley and C. Bondoin, General approaches to the problem of bioequivalence. Statistician, 37, 51-58 (1988).
15. D. Hauschke, V. W. Steinijans and E. Diletti, A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol., 28(2), 72-78 (1990).
16. H. Blume, K. Kubel-Tiel, B. Reutter, M. Siewert and G. Stenzhorn, Monographie zue Prufung der bioverfugbarkeit/bioaquivalenz von schnell-freisetzenden zubereitungen. Pharm. Ztg., 133, 389-393 (1988).
17. J. E. Grizzle, The two-period change-over design and its use in clinical trials. Biometrics, 21, 467-480 (1965).
18. W. J. Westlake, Biopharmaceutical Statistics for Drug Development. Dekker, New York, 1988, Ch 5.
19. D. Mandallaz and J. Mau, Comparison of different methods of decision making in bioequivalence assessment. Biometrics, 37, 213-222 (1981).
20. D. J. Schuirman, A comparison of two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J. Pharmacokinet. Biopharm., 715, 657-680 (1987).
21. W. J. Westlake, Response to Kirkwood, T. B. L., Bioequivalence testing - a need to rethink. Biometrics, 37, 589-594 (1981).
22. T. Dahl, Naproxen (Naprosyn) pharmacokinetics: therapeutics relevance and tolerance profile. Cephalalgia, 4, 69-75 (1988).
23. T. Dahl, T. Lang and A. Bormeth, Effects of various granulating systems on bioavailability of naproxen sodium from polymeric matrix tablets. J. Pharm. Sci., 79(5), 389-392 (1990).
24. L. S. Simon and J. A. Mills, Drug therapy: nonsteroidal anti-inflammatory drugs (second of two parts). New Engl. J. Med., 302, 1237-1243 (1980).
25. W. J. Westlake, Symmetrical confidence intervals for bioequivalence trials. Biometrics, 32, 741-744 (1976).
26. R. M. McVerry, M. Matin and S. K. Mukerjee, Pharmacokinetics of naproxen in elderly patients. Eur. J. Pharmacol., 31(4), 463-468 (1986).
27. F. M. Dungan, A. W. Kelman and B. Whiting, Naproxen dose and concentration response relationship in rheumatoid arthritis. Br. J. Rheumatology, 27, 48-53 (1988).
28. W. J. Westlake, Use of confidence intervals in analysis of comparative bioavailability trials. J. Pharm. Sci., 61, 1340-1341 (1972).
29. S. Locke, An exact confidence interval from untransformed data for the ratio of two formulation mean. J. Pharmacokinet. Biopharm., 12(6), 649-655 (1984).
30. S. Anderson and W. W. Hauck, A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Commun. Stat. - Theory Methods, 12, 2663-2692 (1983).
31. M. Fluehler, D. Mandallaz and J. Mau, Bayesian approach to bioequivalence assessment. J. Pharm. Sci., 72, 10 (1993).
32. V. W. Steinijans and E. Diletti, Statistical analysis of bioavailability studies; parametric and nonparametric confidence intervals. Eur. J. Clin. Pharmacol., 24, 127-136 (1983).
33. T. B. L. Kirkwood, Bioequivalence testing - a need to rethink. Biometrics, 7, 589-591 (1981).
34. U. S. Pharmacopoeia 23, National Formulary 18, United States Pharmacopeial Convention, Inc., Twinbrook Parkway, Rockville, MD, 1995, p. 1929.
35. G. Caille, P. Souch, P. G. Besner and M. Vezina, Effect of concurrent sucralfate administration of pharmacokinetics of naproxen. Am. J. Med., 83, 67-73 (1987).
36. G. Caille, P. Souch, P. Gervais and P. G. Besner, Single dose pharmacokinetics of ketoprofen, indomethacin and naproxen taken alone or with sucralfate. Biopharm. Drug Disposit., 8, 173-183 (1987).