Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen.

According to the Ibuprofen Product-Specific Bioequivalence Guidance of the European Medicines Agency, achiral bioanalytical methods are considered acceptable for demonstration of bioequivalence of ibuprofen-containing products. The aim of this investigation is to compare the bioequivalence outcomes obtained with individual R and S ibuprofen enantiomers and the sum of both enantiomers from bioequivalence studies in which new intravenous ibuprofen products were compared with oral ibuprofen products. Bioequivalence was assessed for S and R enantiomers of ibuprofen and the sum of both enantiomers, which was calculated to represent the results that would have been obtained with an achiral assay.

Investigation on the Existence of Sex-By-Formulation Interaction in Bioequivalence Trials.

The US Food and Drug Administration recommends that if a drug product is intended for use in both sexes, similar proportions should be recruited for bioequivalence (BE) studies. In contrast, in Europe, subjects can belong to either sex. Literature suggesting the existence of sex-by-formulation interaction (S × F) is limited to few studies.

Sex-by-formulation interaction in bioequivalence trials with transdermal patches.

Purpose: The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are not similar to those obtained in the other sex.

Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.

Aims: The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are not similar to those obtained in the other sex.