Alstrup Astrup (cowgreen68)

The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the presence and role of PED in drug approval and translation into product label claims. PED reported in approval packages of the 48 drugs approved by FDA's Center for Drug Evaluation and Research in 2019 was identified and categorized. Donafenib cost PED in the form of clinical outcome assessments (COAs) was characterized by endpoint positioning and outcome. The product labels were analyzed for PED-related claims. PED was reported as relevant for 39 of 48 (81.3%) drugs approved in 2019. COAs were the predominant PED type; other PED was identified for only 9 (18.8%) drugs, and none included qualitative or patient preference studies. COAs were the only type of PED for which associated claims were identified in the product labels. 27 out of 48 (56.3%) labels contained one or more efficacy claims based on COAs; of these, patient-reported outcomes were the most prevalent with claims identified in 19 labels (39.6%). There are ample opportunities for incorporating PED beyond COAs to inform drug development and facilitate availability of medicines tailored to patient needs. A higher level of transparency on the role of PED in regulatory decision-making and a clear path to PED-based label claims could incentivize sponsors and enable patient empowerment in treatment decisions. There are ample opportunities for incorporating PED beyond COAs to inform drug development and facilitate availability of medicines tailored to patient needs. A higher level of transparency on the role of PED in regulatory decision-making and a clear path to PED-based label claims could incentivize sponsors and enable patient empowerment in treatment decisions.The study was conducted to determine the effects of cultivar, harvest period and their interaction on the hydrophilic phenolic components extra virgin olive oils of the cultivars 'Ayvalık', 'Memecik' and 'Topakaşı'. Olives were collected at three different harvesting periods; (1) early harvest period-1 (Beginning of spotting), (2) early harvest period-2 (End of spotting), and (3) optimum harvest period. Oils were extracted using an abencor system. HPLC (High-performance liquid chromatograph) technique was used to quantify The phenolic compounds including tyrosol (p-HPEA), hydroxytyrosol (3,4-DHPEA), luteolin, rutin, quercetin, catechin, sinapinic acid, p-coumaric acid, cinnamic acid, vanillin, vanillic acid, ferulic acid and gallic acid were quantified using HPLC. The results indicated that the effects of harvest period on the phenolic components were variety dependent. At the early harvest period-1, 'Memecik' and 'Topakaşı' had the highest efficiency in luteolin, cinnamic acid, vanillic acid, and ferulic acid contents, while 'Ayvalık' had the highest efficiency in hydroxytyrosol, sinapinic acid, p-coumaric, vanillin and ferulic acid contents. At the optimum harvest period, 'Ayvalık' had the highest efficiency in luteolin, tyrosol and gallic acid contents, while 'Topakaşı' had the highest efficiency in tyrosol, hydroxytyrosol and rutin content. The highest phenolic content was detected in the early harvest period-1. The content of tyrosol linearly increased with the progress of maturity harvest period, whereas the contents of the sinapinic acid, vanillin, vanilic acid and ferulic acid decreased. The oils of 'Memecik' variety had significantly higher phenolic content than those of 'Ayvalık' and 'Topakaşı' varieties. Male sex, high BMI, narrow pelvis, and bulky mesorectum were acknowledged as clinical variables correlated with a difficult pelvic dissection in colorectal surgery. This paper aimed at comparing pelvic biometric measurements in female and male patien