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| http://dx.doi.org/10.3389/fpsyt.2024.1471609 | DOI Listing |
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Front Med (Lausanne)
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Gispen4Regulatory Science Consultancy, Bilthoven, Netherlands.
The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP.
View Article and Find Full Text PDFPhosphate rebinding induces force reversal via slow backward cycling of cross-bridges.
Front Physiol
January 2025
Institute of Vegetative Physiology, University of Cologne, Köln, Germany.
Objective: Previous studies on muscle fibers, myofibrils, and myosin revealed that the release of inorganic phosphate (P) and the force-generating step(s) are reversible, with cross-bridges also cycling backward through these steps by reversing force-generating steps and rebinding P. The aim was to explore the significance of force redevelopment kinetics (rate constant ) in cardiac myofibrils for the coupling between the P binding induced force reversal and the rate-limiting transition for backward cycling of cross-bridges from force-generating to non-force-generating states.
Methods: and force generation of cardiac myofibrils from guinea pigs were investigated at 0.
Predicting the outcome of a kidney transplant involving a living donor advances donor decision-making donors for clinicians and patients. However, the discriminative or calibration capacity of the currently employed models are limited. We set out to apply artificial intelligence (AI) algorithms to create a highly predictive risk stratification indicator, applicable to the UK's transplant selection process.
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