Search results for "pharmaceutical"

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes

2014

Objective The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. Methods The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills w…

Absorption of drugs from the bladder and intravesical chemotherapy

1976

Comment on: Tocilizumab induces corticosteroid sparing in rheumatoid arthritis patients in clinical practice: reply

2015

Type de document : lettre à l'éditeur; International audience

The evolution of European Medicines Agency drug approval: the adaptive licensing: Table 1

2015

In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations. The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authori…

Gestational diabetes and the metabolic syndrome: Can obesity and small, dense low density lipoproteins be key mediators of this association?

2013

Gestational diabetes mellitus (GDM) represents a condition of glucose intolerance with first appearance or recognition at the time of a pregnancy, associated with an inadequate pancreatic response to the advanced insulin resistance of the later stages of pregnancy, and accompanied by enhancing β-cell mass and secretion of insulin. Women who had GDM exhibit a higher risk for later advent of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). Additionally, previous GDM has been proposed as independently correlated with higher risk for development of atherosclerosis in a healthy population, similar to the metabolic syndrome (MetS) and independently of the presence of established…

Resistin: An Inflammatory Cytokine. Role in Cardiovascular Diseases, Diabetes and the Metabolic Syndrome

2014

Resistin is an adipocyte- and monocyte-derived cytokine which has been implicated in the modulation of insulin action, energy, glucose and lipid homeostasis. Resistin has been associated with insulin resistance and many of its known complications. As a molecular link between metabolic signals, inflammation, and vascular dysfunction, resistin can be proposed as playing a significant role in the heightened inflammatory state induced by metabolic stress linked to excessive caloric intake, thus contributing to the risk for metabolic syndrome (MetS), type 2 diabetes (T2DM), and cardiovascular diseases (CVD). In this review, we highlighted the role of resistin, as an inflammatory cytokine, in the…

Advances in detection and characterization of atherosclerosis using contrast agents targeting the macrophage

2006

With advances in imaging technology and our understanding of the role of inflammation in atherosclerosis, the macrophage appears to be an excellent target for imaging the progression of disease. In addition to imaging the macrophage with only 1 modality, contrast agents can be created that can be imaged with multiple modalities. This seems extremely attractive, as lesion morphology and characteristics can be determined with modalities that provide high picture resolution, such as CT or MRI, whereas macrophage quantity can be accurately determined through the creation of a radiolabeled contrast agent such as FDG via PET. Although this combination of imaging technologies may yield clinically …

Endothelin action on goat cerebral arteries.

1990

Abstract Cumulative application of endothelin-1 (human) markedly constricted goat isolated cerebral arteries in a concentration-dependent manner. Contractile responses were not affected by removal of endothelial cells. Removal of extracellular calcium or addition of the calcium channel blocker nicardipine (10−7 M) failed to abolish responses to endothelin. The results suggest that the endothelium-independent constriction of cerebral arteries produced by endothelin cannot be explained solely by voltage-dependent calcium channels. The contractile responses are likely to be mediated by stimulation of specific receptors for this peptide.

Stability of a Parenteral Formulation of Betamethasone and Levobupivacaine

2014

Background: The therapeutic management of syndromes presenting simultaneously pain and inflammation often requires the administration of anesthetic and corticosteroid drugs by epidural administration. In this article, we studied a mixture that combines betamethasone and levobupivacaine, which demonstrates prolonged analgesic effects. To our knowledge, the stability of such a mixture in epidural solution has not been examined. Objective: To evaluate the chemical, physical, and microbiological stability of an extemporaneously prepared mixture. Methods: A solution of betamethasone acetate 1 mg/mL, betamethasone phosphate 1 mg/mL, and levobupivacaine hydrochloride 0.83 mg/mL was prepared in sa…

Cigarette smoke-induced pulmonary endothelial dysfunction is partially suppressed by sildenafil.

2009

Abstract Cigarette smoke mediated oxidative stress and endothelial dysfunction are important processes in the pathogenesis of several lung disorders. In this study we evaluated the effect of PDE5 inhibition on pulmonary artery endothelial dysfunction induced by cigarette smoke in vitro . Human pulmonary artery endothelial cells (HPAEC) were incubated in the absence or presence of PDE5 inhibitor sildenafil (10 nM–1 μM), PKG agonist 8-Br-cGMP (1 mM), or the antioxidants dyphenyleneiodonium (DPI 1 μM) and N -acetylcysteine (NAC 1 mM) for 30 min. Then, cigarette smoke extract (CSE) was added for 24 h. CSE (2.5–10%)-induced ROS generation was suppressed by DPI, and partially reversed by sildenaf…