Notes

Evaluation of a new satellite-based cyanobacteria blossom diagnosis criteria using field-measured microcystin information.
identify predator and resource abundance as two main potential drivers of the personality-mediated trade-off and emphasize that future work on the POLS hypothesis would benefit from an approach integrating behaviour and life history across ecological conditions.
The immunosuppressant everolimus is increasingly applied in renal transplantation. Its extensive pharmacokinetic variability necessitates therapeutic drug monitoring, typically based on whole-blood trough concentrations (C
). Unfortunately, therapeutic drug monitoring target attainment rates are often unsatisfactory and patients with on-target exposure may still develop organ rejection. As everolimus displays erythrocyte partitioning, haematocrit-normalised whole-blood exposure has been suggested as a more informative therapeutic drug monitoring marker. Furthermore, model-informed precision dosing has introduced options for more sophisticated dose adaptation. We have previously developed a mechanistic population pharmacokinetic model, which described everolimus plasma pharmacokinetics and enabled estimation of haematocrit-normalised whole-blood exposure. AMG232 Here, we externally evaluated this model for its utility for model-informed precision dosing.

The retrospective dataset included 4123 pharmacokinetic obely predict future everolimus exposure from prior pharmacokinetic measurements. In addition, we illustrated the potential added value of performing everolimus therapeutic drug monitoring with haematocrit-normalised whole-blood concentrations. Our results provide reassurance to implement this methodology in clinical practice for further evaluation.Calcineurin inhibitors, the primary immunosuppressive therapy used to prevent alloreactivity of transplanted organs, have a narrow therapeutic index. Currently, treatment is individualized based on clinical assessment of the risk of rejection or toxicity guided by trough concentration monitoring. Advances in immune monitoring have identified potential markers that may have value in understanding calcineurin inhibitor pharmacodynamics. Integration of these markers has the potential to complement therapeutic drug monitoring. Existing pharmacokinetic-pharmacodynamic (PK-PD) data is largely limited to correlation between the biomarker and trough concentrations at single time points. Immune related gene expression currently has the most evidence supporting PK-PD integration. Novel biomarker-based approaches to pharmacodynamic monitoring including development of enhanced PK-PD models are proposed to realize the full clinical benefit.
Patients with asthma typically increase short-acting β
-agonists (SABA) use with worsening symptoms. Excessive SABA use may lead to a higher risk of adverse outcomes. We evaluated, in a large population cohort, an association between SABA inhaler use and asthma exacerbations and healthcare utilization.

As part of the SABINA (SABA use IN Asthma) global program, we conducted a retrospective longitudinal observational study (SABINA I) using UK primary care electronic healthcare records (Clinical Practice Research Datalink; 2007-2017) from asthma patients aged ≥ 12years. SABA inhaler use was classified as 'high use', ≥ 3 canisters/year versus 'low use', 0-2canisters/year. Taking into consideration all their asthma prescriptions, patients were categorized into a treatment step according to 2016 British Thoracic Society (BTS) asthma management guidelines. Multivariable regression assessed the association of SABA inhaler use by BTS treatment steps (grouped as BTS steps 1/2 and 3-5), separately, and with outcome BTS steps and was associated with a significant increase in exacerbations and asthma-related healthcare utilization.Effective responses to a global pandemic require local action. In the face of a pandemic or similar emergencies, communities of people who use drugs face risks that result from their ongoing drug use, reduced ability to secure treatment for drug use and correlated maladies, lack of access to preventive hygiene, and the realities of homelessness, street-level policing, and criminal justice involvement. Herein, we document the efforts of a coalition of people who use drugs, advocates, service providers, and academics to implement solutions to reduce these risks at a municipal and state level focusing on New Haven and the State of Connecticut. This coalition identified the communities at risk active users needing access to harm reduction services, persons in treatment needing access to their medications, the homeless and marginally housed needing improved hygiene, people engaged in sex work, and the incarcerated needing release from custody. The section describing each of the risks demonstrates how the coalition acted preemptively at early stages of the pandemic, ahead of official initiatives, to develop ameliorative risk reduction solutions. Outcomes discussed include instances in which obstacles were overcome or still remain.
Completeness of adverse event (AE) reports is an important component of quality for good pharmacovigilance practices. We aimed to evaluate the impact of incorporating a measure of completeness of AE reports on quantitative signal detection.

An internal safety database from a global pharmaceutical company was used in the analysis. vigiGrade, an index score of completeness, was derived for each AE report. Data from various patient support programs (PSPs) were categorized based on average vigiGrade score per PSP. Performance of signal detection was compared between (1) weighting and not weighting by vigiGrade score; and, (2) well documented and poorly documented PSPs using sensitivity, specificity, area under the receiver operating characteristics curve (AUC) and time-to-signal detection.

The ability to detect signals did not differ significantly when weighting by vigiGrade score [sensitivity (50% vs. 45%, p = 1), specificity (82.8% vs. 82.8%, p = 1), AUC (0.66 vs. 0.63, p = 0.051) or time-to-signal detectlf.Regulatory agencies across the Latin American region have strengthened their activities through the development of new regulatory science-based tools, standards and other approaches to evaluate and assess the safety, efficacy, quality and performance of therapeutics and devices. These processes have been implemented to promote the development and authorization of innovative new drugs and technologies, which pose a challenge to even well-established regulatory frameworks. Furthermore, in today's environment, the regulatory framework to protect public health can create barriers to marketing entry of novel drugs and medical devices. This article describes the pioneering approach that the Cuban regulatory agency (CECMED) has developed with the aim of building a comprehensive regulatory framework geared to accelerated innovation and enable successful transition of novel products from research and development to clinical practice. The Office of Innovation recently established at CECMED is the first flagship initiative of this type in Latin America and the Caribbean region.
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