When the COVID-19 pandemic first emerged in early 2020, healthcare and bureaucratic systems worldwide were caught off guard and largely unprepared to deal with the scale and severity of the outbreak. In Italy, this led to a severe underreporting of infections during the first wave of the spread. The lack of accurate data is critical as it hampers the retrospective assessment of nonpharmacological interventions, the comparison with the following waves, and the estimation and validation of epidemiological models.
View Article and Find Full Text PDFEarly detection of the emergence of a new variant of concern (VoC) is essential to develop strategies that contain epidemic outbreaks. For example, knowing in which region a VoC starts spreading enables prompt actions to circumscribe the geographical area where the new variant can spread, by containing it locally. This paper presents 'funnel plots' as a statistical process control method that, unlike tools whose purpose is to identify rises of the reproduction number ([Formula: see text]), detects when a regional [Formula: see text] departs from the national average and thus represents an anomaly.
View Article and Find Full Text PDFDespite progress in clinical care for patients with coronavirus disease 2019 (COVID-19), population-wide interventions are still crucial to manage the pandemic, which has been aggravated by the emergence of new, highly transmissible variants. In this study, we combined the SIDARTHE model, which predicts the spread of SARS-CoV-2 infections, with a new data-based model that projects new cases onto casualties and healthcare system costs. Based on the Italian case study, we outline several scenarios: mass vaccination campaigns with different paces, different transmission rates due to new variants and different enforced countermeasures, including the alternation of opening and closure phases.
View Article and Find Full Text PDFHealth authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro-in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is frequently required, increasing the cost and time of drug development. This study focused on developing a Level A IVIVC for progesterone vaginal rings (PVRs), a dosage form designed for the continuous delivery in vivo.
View Article and Find Full Text PDFObjective: Pulsatile insulin secretion is impaired in diseases such as type 2 diabetes that are characterized by insulin resistance. This has led to the suggestion that changes in insulin pulsatility directly impair insulin signaling. We sought to examine the effects of pulse characteristics on insulin action in humans, hypothesizing that a decrease in pulse amplitude or frequency is associated with impaired hepatic insulin action.
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