ArticleBritish journal of clinical pharmacology2018
Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.
Article in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed.
- Sex-by-formulation interaction in bioequivalence trials with transdermal patches.European journal of clinical pharmacology · 2019Review
- Response to 'Sex-by-formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions' by Ibarra et al.British journal of clinical pharmacology · 2019Article
- Sex-by-formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions.British journal of clinical pharmacology · 2019Article
- Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.British journal of clinical pharmacology · 2018Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe 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. Therefore, results obtained in studies including only males would not be representative of the results that would have been obtained in females and vice versa. Recently, a sex-by-formulation interaction has been reported in a study for efavirenz tablets. The purpose of this paper is to investigate whether a sex-by-formulation interaction is actually observed in the bioequivalence studies conducted with efavirenz tablets.
methodsThe existence of sex-by-formulation interaction was investigated in the two studies conducted in our centre, where the same test and reference products were investigated in a pilot study with 12 subjects and a pivotal study with 36 subjects.
resultsIn the pilot study, the point estimates for the test/reference ratio of geometrics means of C
conclusionsA sex-by-formulation interaction is suggested in the study with a small sample size, but it disappears when the study is repeated with a larger sample size. In conclusion, the analysis of subgroups should be conducted with caution when the size of the subgroups is not powered to show bioequivalence. There seems to be no reason to require bioequivalence studies for efavirenz in both sexes.
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