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Introduction. Oncologic mastectomy in the setting of obesity poses challenges in achieving a flat closure that includes the lateral adiposity. The angel wing (AW) technique was developed to address this issue. We aim to demonstrate the safety of AW by evaluating incidence of arm lymphedema (AL) and decreased range of motion (dROM) in patients postmastectomy with and without the AW closure. Methods. We performed a single-center retrospective cohort study at an academic referral center of patients who underwent mastectomy with and without the AW technique from May 2014 to October 2022. Those who received breast reconstruction (immediate or delayed), partial mastectomy, and male patients were excluded. The presence of postoperative AL and dROM was evaluated. Subgroup analysis was performed for patient factors including BMI, extent of axillary surgery, PMRT, and pathologic stage. Results. A total of 390 patients met inclusion criteria. Of those, 173 (44.4%) underwent AW and 217 (55.6%) had non-AW mastectomy. Expectedly, the average BMI was significantly higher in the AW cohort (p < 0.0001). The overall rate of AL was 51/390 (13.1%), seen in 27 (15.6%) undergoing AW and 24 (11.1%) non-AW (p value = 0.18). While the rate of dROM within the cohort was 52/390 (13.1%), 27 (15.6%) underwent AW vs. 24 (11.1%) non-AW (p value = 0.22), resulting in no statistical significance between AW and non-AW mastectomy upon subsequent development of AL or dROM. Conclusion. Our study demonstrates the AW technique does not convey an increased risk of overall AL or dROM, even when considering known risk factors such as obesity, PMRT, and extent of axillary surgery. As we strive to provide our patients with improved surgical techniques for oncologic resection, we submit that this technique is a viable and safe option for achieving the goals of cosmesis with oncologic safety. [ABSTRACT FROM AUTHOR]

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. To investigate if S × F is observed, this work includes 120 BE studies. Differences larger than 20% between the ratio test/reference of women and men or statistically significant S × F occurred in 25 of 120 studies (20.8%). The prevalence is higher in small studies (36.00% vs. 16.8%). Large differences between the ratios of the sex groups are the tails of the distribution. Two studies were repeated, and the differences between the ratios of the sex groups disappeared. The 90% confidence intervals of S × F did not confirm any relevant S × F. There is no evidence to require studies in both sex groups, combined or separately., (© 2019 Spanish Agency of Medicines and Medical Devices. Clinical Pharmacology & Therapeutics© 2019 American Society for Clinical Pharmacology and Therapeutics.)

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. 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., Methods: The 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., Results: In the pilot study, the point estimates for the test/reference ratio of geometrics means of C max in females and males were more than 20% different (95.42% vs.79.38%, i.e., 120.21%), but in a subsequent pivotal study the difference was less than 2% (111.14% vs. 109.98%, i.e., 101.66%)., Conclusions: A 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., (© 2018 The British Pharmacological Society.)