The final FDA PRO Guidance proposes the cumulative Rabusertib distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population.

While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO’s relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.”
“Background: Plasma phospholipid fatty

acids have been correlated with food intakes in populations with homogeneous dietary patterns. However, few data are available on populations with heterogeneous dietary patterns.

Objective: The objective was to investigate whether plasma phospholipid fatty acids are suitable biomarkers GDC-0973 of dietary intakes across populations involved

in a large European multicenter study.

Design: A cross-sectional study design nested to the European Prospective Investigation into Cancer and Nutrition (EPIC) was conducted to determine plasma fatty acid profiles in > 3000 subjects from 16 centers, who had also completed 24-h dietary recalls and dietary questionnaires. Plasma fatty acids were assessed by capillary gas chromatography. Ecological and individual correlations were calculated between fatty acids and select food groups.

Results:

The most important determinant of plasma fatty acids was region, which suggests that the variations across regions are largely due to different food intakes. Strong ecological correlations were observed between fish intake and long-chain n-3 polyunsaturated fatty acids (r = 0.78, P < 0.01), olive oil and oleic acid (r = 0.73, P < 0.01), and margarine and elaidic acid (r = 0.76, P < 0.01). Individual correlations varied across the regions, particularly between olive oil and oleic acid and between alcohol and the WH-4-023 in vitro saturation index, as an indicator of stearoyl CoA desaturase activity.

Conclusions: These findings indicate that specific plasma phospholipid fatty acids are suitable biomarkers of some food intakes in the EPIC Study. Moreover, these findings suggest complex interactions between alcohol intake and fatty acid metabolism, which warrants further attention in epidemiologic studies relating dietary fatty acids to alcohol-related cancers and other chronic diseases. Am J Clin Nutr 2009; 89: 331-46.”
“Next to existing terminology of the lower urinary tract, due to its increasing complexity, the terminology for pelvic floor dysfunction in women may be better updated by a female-specific approach and clinically based consensus report.