Search results for "Medical product"
showing 3 items of 3 documents
Polyoxypregnanes as safe, potent, and specific ABCB1-inhibitory pro-drugs to overcome multidrug resistance in cancer chemotherapy in vitro and in vivo
2021
Multidrug resistance (MDR) mediated by ATP binding cassette subfamily B member 1 (ABCB1) is significantly hindering effective cancer chemotherapy. However, currently, no ABCB1-inhibitory drugs have been approved to treat MDR cancer clinically, mainly due to the inhibitor specificity, toxicity, and drug interactions. Here, we reported that three polyoxypregnanes (POPs) as the most abundant constituents of Marsdenia tenacissima (M. tenacissima) were novel ABCB1-modulatory pro-drugs, which underwent intestinal microbiota-mediated biotransformation in vivo to generate active metabolites. The metabolites at non-toxic concentrations restored chemosensitivity in ABCB1-overexpressing cancer cells v…
Patient-Reported Outcomes and Continuous Glucose Monitoring: Can We Do Better With Artificial Pancreas Devices?
2015
Patient-reported outcomes (PROs) assess a person’s experience, feelings, and thoughts about both their condition and its treatment. PROs are able to contribute to a benefit assessment of new medical products by introducing the patients’ subjective evaluation of medical products into the evaluation process. Thus, PROs are also the cornerstone of medical product development for understanding patients’ perceptions on medical products and/or its benefit assessment. In the past 15 years, PROs were also evaluated in most clinical trials performed with continuous glucose monitoring systems. However, in its recent evaluation of such trials, the German Institute for Quality and Efficiency in Health …
New falsified medicinal products’ distribution prevention regulation: legal issues and good distribution practice for pharmaceutical companies
2019
The aim of this paper is to analyse the impact of new falsified medicinal products’ distribution prevention regulation on distributors and patients’ rights in Latvia. Starting from the late 2000s the validity of the medicinal products became one of the most important issues to be considered, as the level of falsified medicinal products sales significantly increased. In order to solve this issue, the Directive 2011/62 / EC (3) on falsified medicinal products for human use was introduced and now serves as a basis for the distribution of medicinal products, which only allows licensed pharmacies and approved retailers, including approved Internet service providers, to be included into the movem…