Analysis of safety parameters for the MINERVE reactor

Kerntechnik ◽  
2015 ◽  
Vol 80 (3) ◽  
pp. 241-254
Author(s):  
A. E. Ateya ◽  
E. H. Amin ◽  
M. E. Nagy ◽  
H. H. Abou-Gabal
Keyword(s):  
Safety Parameters

Novel Targets For Therapeutic Intervention in Inflammatory Bowel Disease. What is the Best Way to Assess the Safety Profile of a Drug?

2019 ◽  
Vol 25 (1) ◽  
pp. 57-63 ◽  
Author(s):  
Clara Yzet ◽  
Stacy S. Tse ◽  
Maia Kayal ◽  
Robert Hirten ◽  
Jean-Frédéric Colombel
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Evaluation Process ◽  
Population Based ◽  
Stage Of Development ◽  
Remission Rates ◽  
Safety Parameters ◽  
Post Marketing ◽  
Inflammatory Bowel

The emergence of biologic therapies has revolutionized the management of inflammatory bowel disease (IBD) by halting disease progression, increasing remission rates and improving long-term clinical outcomes. Despite these well-described benefits, many patients are reluctant to commence therapy due to drug safety concerns. Adverse events can be detected at each stage of drug development and during the post-marketing period. In this article, we review how to best assess the safety parameters of new IBD medications, from the earliest stage of development to population-based registries, with a focus on the special populations often excluded from the evaluation process.

Application of Advanced Technologies in Natural Product Research: A Review with Special Emphasis on ADMET Profiling

2020 ◽  
Vol 21 (10) ◽  
pp. 751-767
Author(s):  
Pobitra Borah ◽  
Sangeeta Hazarika ◽  
Satyendra Deka ◽  
Katharigatta N. Venugopala ◽  
Anroop B. Nair ◽  
...  
Keyword(s):  
Drug Discovery ◽  
Natural Product ◽  
Dynamic Range ◽  
Early Stage ◽  
Attrition Rate ◽  
Drug Candidates ◽  
Advanced Technologies ◽  
Natural Product Research ◽  
The Status ◽  
Safety Parameters

The successful conversion of natural products (NPs) into lead compounds and novel pharmacophores has emboldened the researchers to harness the drug discovery process with a lot more enthusiasm. However, forfeit of bioactive NPs resulting from an overabundance of metabolites and their wide dynamic range have created the bottleneck in NP researches. Similarly, the existence of multidimensional challenges, including the evaluation of pharmacokinetics, pharmacodynamics, and safety parameters, has been a concerning issue. Advancement of technology has brought the evolution of traditional natural product researches into the computer-based assessment exhibiting pretentious remarks about their efficiency in drug discovery. The early attention to the quality of the NPs may reduce the attrition rate of drug candidates by parallel assessment of ADMET profiling. This article reviews the status, challenges, opportunities, and integration of advanced technologies in natural product research. Indeed, emphasis will be laid on the current and futuristic direction towards the application of newer technologies in early-stage ADMET profiling of bioactive moieties from the natural sources. It can be expected that combinatorial approaches in ADMET profiling will fortify the natural product-based drug discovery in the near future.

Dynamic RT Modelling and 3D Visualization of Critical Safety Parameters on Drillfloor During Drilling, Running Liners & Screens and Cementing of Challenging Offshore Wells

2020 ◽  
Author(s):  
Rolv Rommetveit ◽  
Josef Nabavi ◽  
Sven Inge Ødegård ◽  
Maryam Gholami Mayani ◽  
Svein Syltøy ◽  
...  
Keyword(s):  
3D Visualization ◽  
Safety Parameters

scholarly journals Regulation of Alcohol and Acetaldehyde Metabolism by a Mixture of Lactobacillus and Bifidobacterium Species in Human

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1875
Author(s):  
Su-Jin Jung ◽  
Ji-Hyun Hwang ◽  
Eun-Ock Park ◽  
Seung-Ok Lee ◽  
Yun-Jo Chung ◽  
...  
Keyword(s):  
Alcohol Dehydrogenase ◽  
Blood Levels ◽  
Double Blind ◽  
Excessive Alcohol Consumption ◽  
Bifidobacterium Species ◽  
Placebo Capsule ◽  
Safety Parameters ◽  
Excessive Alcohol ◽  
Clinically Significant ◽  
Acetaldehyde Metabolism

Excessive alcohol consumption is one of the most significant causes of morbidity and mortality worldwide. Alcohol is oxidized to toxic and carcinogenic acetaldehyde by alcohol dehydrogenase (ADH) and further oxidized to a non-toxic acetate by aldehyde dehydrogenase (ALDH). There are two major ALDH isoforms, cytosolic and mitochondrial, encoded by ALDH1 and ALDH2 genes, respectively. The ALDH2 polymorphism is associated with flushing response to alcohol use. Emerging evidence shows that Lactobacillus and Bifidobacterium species encode alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) mediate alcohol and acetaldehyde metabolism, respectively. A randomized, double-blind, placebo-controlled crossover clinical trial was designed to study the effects of Lactobacillus and Bifidobacterium probiotic mixture in humans and assessed their effects on alcohol and acetaldehyde metabolism. Here, twenty-seven wild types (ALDH2*1/*1) and the same number of heterozygotes (ALDH2*2/*1) were recruited for the study. The enrolled participants were randomly divided into either the probiotic (Duolac ProAP4) or the placebo group. Each group received a probiotic or placebo capsule for 15 days with subsequent crossover. Primary outcomes were measurement of alcohol and acetaldehyde in the blood after the alcohol intake. Blood levels of alcohol and acetaldehyde were significantly downregulated by probiotic supplementation in subjects with ALDH2*2/*1 genotype, but not in those with ALDH2*1/*1 genotype. However, there were no marked improvements in hangover score parameters between test and placebo groups. No clinically significant changes were observed in safety parameters. These results suggest that Duolac ProAP4 has a potential to downregulate the alcohol and acetaldehyde concentrations, and their effects depend on the presence or absence of polymorphism on the ALDH2 gene.

scholarly journals Evolution of Food Safety Features and Volatile Profile in White Sturgeon Caviar Treated with Different Formulations of Salt and Preservatives during a Long-Term Storage Time

Foods ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 850
Author(s):  
Annalaura Lopez ◽  
Federica Bellagamba ◽  
Erica Tirloni ◽  
Mauro Vasconi ◽  
Simone Stella ◽  
...  
Keyword(s):  
Food Safety ◽  
Organic Acids ◽  
Solid Phase ◽  
Current Trend ◽  
Storage Period ◽  
Storage Conditions ◽  
Sensory Profile ◽  
Volatile Profile ◽  
Safety Parameters ◽  
Statistic Model

Caviar is a semi-preserved fish preparation in which cold storage (around 0 °C) and packaging under anaerobic conditions are fundamental to guarantee adequate safety parameters. Consumers seem to prefer caviar prepared with food salt only, but according to the needs of the different distribution channels, some preservatives are used in order to prolong its shelf life and to allow less restrictive storage conditions. Traditionally, the most common preservative was sodium tetraborate (borax), a salt that contributes to the sensory profile of caviar. However, due to its toxicity, borax has been banned in many countries, and the current trend is to reduce or eliminate its use. In this study, we evaluated the evolution of food safety parameters (pH, water activity, microbiological parameters) and the volatile profile during 14 months of storage in caviar samples treated with three different preservatives: I. exclusively NaCl, II. a mixture of borax and NaCl, and III. a mixture of organic acids and salts. Microbial presence was studied by means of plate counts; volatile organic compounds were identified on the sample headspace by means of solid phase microextraction with gas-chromatography and mass spectrometry. Results showed relevant differences among the three treatments investigated, with salt samples characterized by the highest viable counts and the greatest presence of volatile products driven by oxidative and spoilage processes, mainly occurring toward lipid and amino acids. On the contrary, the mixture of organic acids and salts showed the best response during the entire storage period. Finally, the employment of a multiparametric statistic model allowed the identification of different clusters based on the time of ripening and the preservative treatments used.

Optimization of Safety Parameters and Accident Mitigation Measures for Innovative Fast Reactor Concepts

2012 ◽  
Vol 61 (1T) ◽  
pp. 155-160 ◽  
Author(s):  
B. Vezzoni ◽  
X.-N. Chen ◽  
M. Flad ◽  
F. Gabrielli ◽  
M. Marchetti ◽  
...  
Keyword(s):  
Fast Reactor ◽  
Mitigation Measures ◽  
Safety Parameters

Comparison of the Safety of Standard and Triple Dose Gadodiamide Injection in MR Imaging of the Central Nervous System

1994 ◽  
Vol 35 (4) ◽  
pp. 396-399 ◽  
Author(s):  
M. G. Svaland ◽  
T. Christensen ◽  
E. Lundorf
Keyword(s):  
Mr Imaging ◽  
Adverse Events ◽  
Contrast Enhancement ◽  
Dose Group ◽  
Serum Bilirubin ◽  
Diagnostic Yield ◽  
Blood Chemistry ◽  
New Information ◽  
Safety Parameters ◽  
The Central Nervous System

Gadodiamide injection was administered intravenously to 49 patients with known or suspected CNS lesions undergoing MR imaging. Two parallel groups were used to evaluate the efficacy and safety of single doses of 0.1 (25 patients) and 0.3 (24 patients) mmol/kg b.w. The principal measures of efficacy were diagnostic yield of MR and the overall contrast enhancement. Adverse events and serum bilirubin were the main safety parameters. Contrast enhancement of the lesion was observed for 16 patients in each dose group. Thirteen patients in the 0.1 and 17 in the 0.3 mmol/kg group had their diagnosis amended following the postcontrast image, but only one patient in each dose group had their management affected by new information from the postcontrast image. The overall diagnostic utility of gadodiamide injection was good, but there were no differences between the 2 doses studied in this respect. No injection-associated discomfort or other adverse events were reported. No clinically important changes in serum bilirubin, or other parameters of blood chemistry, or hematology were observed. Overall, the safety profile of gadodiamide injection 0.3 mmol/kg b.w. in this study was similar to that of 0.1 mmol/kg b.w.

Open Multicentre Study of the P 2T Receptor Antagonist AR-C69931MX Assessing Safety, Tolerability and Activity in Patients with Acute Coronary Syndromes

2001 ◽  
Vol 85 (03) ◽  
pp. 401-407 ◽  
Author(s):  
Keith Oldroyd ◽  
Robert Wilcox ◽  
Robert Storey ◽  
Keyword(s):  
Platelet Aggregation ◽  
Receptor Antagonist ◽  
Acute Coronary Syndromes ◽  
Plasma Concentrations ◽  
Antithrombotic Agent ◽  
Serious Adverse Events ◽  
Central Process ◽  
Impedance Aggregometry ◽  
Safety Parameters ◽  
Coronary Syndromes

SummaryPlatelet aggregation is the central process in the pathophysiology of acute coronary syndromes. ADP contributes to thrombosis by activating platelets, and AR-C69931MX is a specific antagonist of this process acting at the P 2T receptor. At 5 hospitals, 39 patients with unstable angina or non-Q wave myocardial infarction, who were receiving aspirin and heparin, were administered intravenous AR-C69931MX with stepped dose increments over 3 h to a plateau of either 2 μg/kg/min for 21 h (Part 1; n = 12) or up to 69 h (Part 2; n = 13) or 4 μg/kg/min for up to 69 h (Part 3: n = 14). Safety parameters, platelet aggregation (PA) induced by ADP 3 μmol/L (impedance aggregometry), bleeding time (BT) and plasma concentrations of AR-C69931XX were assessed. AR-C69931MX was well tolerated. 33 patients completed the study. There were no deaths at 30 days and no serious adverse events attributed to AR-C69931MX. Trivial bleeding (56%) was common. At 24 h, mean inhibition of PA was 96.0 ± 8.6, 94.9 ± 14.4 and 98.7 ± 2.1% and BT was 9.5 ± 8.4, 14.0 ± 9.7 and 16.0 ± 11.1 min for Parts 1, 2 and 3 respectively. At 1 h post-infusion, mean inhibition of PA was 36.2 ± 39.2, 20.7 ± 25.9 and 40.7 ± 36.7% respectively. 90% patients had a plasma half-life for AR-C69931XX of 9 min. In conclusion, AR-C69931MX is a potent, short-acting platelet ADP receptor antagonist suitable for further studies as an antithrombotic agent.

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