Bioequivalence of two formulations of piroxicam.
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.
Michotte
Y
Y
Laboratory for Pharmaceutical Chemikstry and Drug analysis, Vrije Universiteit Brussel (Belgium)
Van Klaveren
H P
HP
Detaevenier
M R
MR
Gusdorf
C F
CF
Vanhaelst
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D008297:Male; D010894:Piroxicam / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D013488:Suppositories; D013607:Tablets; D013810:Therapeutic Equivalency
D013488:Suppositories; D013607:Tablets; D010894:Piroxicam