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Bioequivalence of two formulations of piroxicam
Y Michotte1, H P Van Klaveren, M R Detaevenier
1Laboratory for Pharmaceutical Chemikstry and Drug analysis, Vrije Universiteit Brussel (Belgium)
Arzneimittel-Forschung
|March 1, 1991
Abstract:
Two separate studies were performed with 12 volunteers in order to demonstrate the bioequivalence of 2 piroxicam (CAS 36322-90-4) tablet and 2 piroxicam suppository formulations after single dose administration. A validated reversed-phase HPLC method with UV-detection is described. Bioequivalence assessment was done by using the posterior probability of a mean ratio between 0.8 and 1.2, and by using the Two One-Sided Tests Procedure (i.e. the 90% confidence interval). The probability approach and the confidence interval approach were compared.