Implementation of Patient Reported Outcome Measures (PROMs) in QbD based formulation development in ophthalmology

Development of drug delivery systems for chronic disorders needs a complex thinking in order to ensure the quality of the product. A multidisciplinary approach of pharmaceutical technology, regulatory and behavioral sciences on the basis of the Quality by Design methodology can be a proper tool for this to handle formulators’, patients’, and also doctors’ needs in therapy planning in case of chronic ophthalmologic disorders. According to the present state-of-the-art”, patient perceptions are collected in the form of the “Patient Reported Outcome Measurements” during the clinical trials, but no feedback is given to the formulation development in order to take these aspects into consideration when designing a new product. This work aims to link the key performance indicators from patients’ point of view to the pharmaceutical development and show a new approach to product development by evaluating the patient and formulator aspect as critical quality attributes within the classical Quality by Design workflow. This study can be the basis of the formulation design and development of a new ophthalmic formulation as it revealed the patient critical needs and requirement

Kannabisz használata az onkológiában

Cannabis belongs to the highly prominent soft drugs; after coffee, tobacco and alcohol, it is considered to be the fourth most consumed psychoactive substance. The two most common cannabinoids are the strictly regulated psychotropic delta-9-tetrahydrocannabinol and the dietary supplement cannabidiol, which is non-psychoactive, only subject to reporting obligation and accessible in Hungary since 2004. In relation to the application of medical cannabis, especially in oncological indications, many misconceptions have arisen. In our review, we summarize the history of cannabis, the mechanism of action, the current evidences for application in oncological indications, the legal regulations, and highlight the potential concerns regarding cannabis administration

Small Extracellular Vesicles Isolated from Serum May Serve as Signal-Enhancers for the Monitoring of CNS Tumors

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Prediction of short- and medium-term efficacy of biosimilar infliximab therapy. Do trough levels/antidrug antibody levels or clinical/biochemical markers play a more important role?

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Circulating ACE2 activity predicts mortality and disease severity in hospitalized COVID-19 patients

Objectives Angiotensin-converting enzyme 2 (ACE2) represents the primary receptor for SARS-CoV-2 to enter endothelial cells. Here we investigated circulating ACE2 activity to predict the severity and mortality of COVID-19. Methods Serum ACE2 activity was measured in COVID-19 (110 critically ill and 66 severely ill subjects at hospital admission and 106 follow-up samples) and in 32 non-COVID-19 severe sepsis patients. Associations between ACE2, inflammation-dependent biomarkers, pre-existing comorbidities, and clinical outcomes were studied. Results Initial ACE2 activity was significantly higher in critically ill COVID-19 patients (54.4 [36.7-90.8] mU/L) than in severe COVID-19 (34.5 [25.2-48.7] mU/L; P<0.0001) and non-COVID-19 sepsis patients (40.9 [21.4-65.7] mU/L; P=0.0260) regardless of comorbidities. Circulating ACE2 activity correlated with inflammatory biomarkers and was further elevated during the hospital stay in critically ill patients. Based on ROC-curve analysis and logistic regression test, baseline ACE2 independently indicated the severity of COVID-19 with an AUC value of 0.701 (95% CI [0.621-0.781], P<0.0001). Furthermore, non-survivors showed higher serum ACE2 activity vs. survivors at hospital admission (P<0.0001). Finally, high ACE2 activity (≥45.4 mU/L) predicted a higher risk (65 vs. 37%) for 30-day mortality (Log-Rank P<0.0001). Conclusions Serum ACE2 activity correlates with COVID-19 severity and predicts mortality