Aim. Inadequately controlled diabetes accounts for chronic complications and increases mortality. Its therapeutic management aims in normal HbA1C, prandial and postprandial glucose levels. This review discusses diabetes management focusing on the latest insulin analogues, alternative insulin delivery systems and the artificial pancreas. Results. Intensive insulin therapy with multiple daily injections (MDI) allows better imitation of the physiological rhythm of insulin secretion. Longer-acting, basal insulin analogues provide concomitant improvements in safety, efficacy and variability of glycaemic control, followed by low risks of hypoglycaemia. Continuous subcutaneous insulin infusion (CSII) provides long-term glycaemic control especially in type 1 diabetic patients, while reducing hypoglycaemic episodes and glycaemic variability. Continuous subcutaneous glucose monitoring (CGM) systems provide information on postprandial glucose excursions and nocturnal hypo- and/or hyperglycemias. This information enhances treatment options, provides a useful tool for self-monitoring and allows safer achievement of treatment targets. In the absence of a cure-like pancreas or islets transplants, artificial “closed-loop” systems mimicking the pancreatic activity have been also developed. Conclusions. Individualized treatment plans for insulin initiation and administration mode are critical in achieving target glycaemic levels. Progress in these fields is expected to facilitate and improve the quality of life of diabetic patients.
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
We will present herein data on the synthesis, structural investigation and in vitro antitumor activity of new triorganotin compounds of the general type (R 3 Sn) 2 Q, where R 5 Bu, Ph, Bz, Q 1 5 1,4-dihydroxy-9,10-anthracenedione (quinizarin), Q 2 5 1,5-dihydroxy-9,10-anthracenedione (anthrarufin), Q 3 5 2,3-dihydro-9,10-dihydroxy-1,4-anthracenedione (leucoquinizarin) and R 3 SnQ 4 where Q 4 5 1,2-dihydroxy-9,10-anthracenedione (alizarin). The compounds were synthesized by refluxing the organotin hydroxide with the parent quinone and were characterized by IR, 1 H-NMR and thermal measurements. The spectroscopic analysis of the new triorganotins, provides evidence on the formation of a monodentate Sn-O bond for quinizarin, anthrarufin and leucoquinizarin, which are coordinated to Sn(IV) central atom via the phenolic oxygen donor atoms, with the R-substituents of the organotin moiety completing the tetrahedral coordination environment. On the contrary, organotin alizarinates form a sixmembered chelate ring, which stabilizes the Sn central atom in a five-coordinated environment exhibiting distorted trigonal bipyramidal geometry. The ligand is coordinated to Sn (IV) via the quinoidal oxygen and its neighbouring phenolic one. The new compounds were tested for their cytotoxicity against human tumor and normal cell lines and the results are reported.
Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
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