Computational chemistry solutions supporting chemical safety assessment: Lessons learned for using in silico approaches

2015 ◽  
Vol 238 (2) ◽  
pp. S169-S170
Author(s):  
M. Cronin ◽  
F. Bois ◽  
E. Fioravanzo ◽  
T. Meinl ◽  
D. Neagu ◽  
...  
Keyword(s):  
Computational Chemistry ◽  
In Silico ◽  
Safety Assessment ◽  
Lessons Learned ◽  
Chemical Safety

scholarly journals In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aldo Badano
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Devices ◽  
In Silico ◽  
Lessons Learned ◽  
Patient Access ◽  
High Quality ◽  
Virtual Imaging ◽  
Regulatory Evaluation

AbstractImaging clinical trials can be burdensome and often delay patient access to novel, high-quality medical devices. Tools for in silico imaging trials have significantly improved in sophistication and availability. Here, I describe some of the principal advantages of in silico imaging trials and enumerate five lessons learned during the design and execution of the first all-in silico virtual imaging clinical trial for regulatory evaluation (the VICTRE study).

scholarly journals Safety Assessment of Bacillus subtilis MB40 for Use in Foods and Dietary Supplements

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 733
Author(s):  
Jessica L. Spears ◽  
Richard Kramer ◽  
Andrey I. Nikiforov ◽  
Marisa O. Rihner ◽  
Elizabeth A. Lambert
Keyword(s):  
Antibiotic Resistance ◽  
Bacillus Subtilis ◽  
Dietary Supplements ◽  
Genome Sequencing ◽  
In Silico ◽  
Safety Assessment ◽  
In Vivo Studies ◽  
Strain Identification ◽  
Consumer Safety

With the growing popularity of probiotics in dietary supplements, foods, and beverages, it is important to substantiate not only the health benefits and efficacy of unique strains but also safety. In the interest of consumer safety and product transparency, strain identification should include whole-genome sequencing and safety assessment should include genotypic and phenotypic studies. Bacillus subtilis MB40, a unique strain marketed for use in dietary supplements, and food and beverage, was assessed for safety and tolerability across in silico, in vitro, and in vivo studies. MB40 was assessed for the absence of undesirable genetic elements encoding toxins and mobile antibiotic resistance. Tolerability was assessed in both rats and healthy human volunteers. In silico and in vitro testing confirmed the absence of enterotoxin and mobile antibiotic resistance genes of safety concern to humans. In rats, the no-observed-adverse-effect level (NOAEL) for MB40 after repeated oral administration for 14 days was determined to be 2000 mg/kg bw/day (equivalent to 3.7 × 1011 CFU/kg bw/day). In a 28 day human tolerability trial, 10 × 109 CFU/day of MB40 was well tolerated. Based on genome sequencing, strain characterization, screening for undesirable attributes and evidence of safety by appropriately designed safety evaluation studies in rats and humans, Bacillus subtilis MB40 does not pose any human health concerns under the conditions tested.

Lessons Learned From a Chlorine Gas Leakage in Dezful City, Iran

2020 ◽  
pp. 1-7
Author(s):  
Gholamreza Masoumi ◽  
Mohammad Maniey ◽  
Hamidreza Aghababaeian ◽  
Abbas Ostadtaghizadeh ◽  
Ladan Araghi Ahvazi
Keyword(s):  
Warning System ◽  
Lessons Learned ◽  
Chemical Safety ◽  
Danger Zone ◽  
Khuzestan Province ◽  
Gas Leakage ◽  
Intervention Plan ◽  
Chlorine Gas ◽  
Lack Of Control ◽  
Lack Of Knowledge

Abstract Dezful is the capital of Dezful County, a city in Khuzestan Province, Iran. On August 12, 2017, after a chlorine gas leakage in Dezful, more than 475 people were affected by chlorine gas, and they all suffered from respiratory complications. A lot of problems were encountered in the preparation of the relief forces and organization of the blueprint on how to respond to the incident, such as lack of knowledge on establishment of danger zone, lack of warning system, lack of proper triage and absence of decontamination plans, lack of special chemical safety outfit and respiratory equipment for rescuers, lack of instructions for proper handling, lack of knowledge in dealing with this type of disaster, and inappropriate evacuation skills and failure to cordon off and insure the location of the incident. Although the initial measures to arrest this crisis was performed based on the health system’s instructions of the country with regard to all the possible risks, lack of a comprehensive inter-organizational program and prevention plans, lack of control plans, lack of adequate preparation and response to chemical poisoning, lack of foresight, lack of a risk plan, and lack of an intervention plan for these incidents were the reasons for the damages and problems encountered after the crisis.

scholarly journals Carcinogenicity assessment: technical and political challenges

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
F Madia ◽  
A Worth ◽  
M Whelan ◽  
R Corvi
Keyword(s):  
Public Health ◽  
Safety Assessment ◽  
Chemical Exposure ◽  
Chemical Production ◽  
Chemical Safety ◽  
Cancer Disease ◽  
Cancer Occurrence ◽  
Global Trend ◽  
Exposure Patterns ◽  
Prevention Of Cancer

Abstract The rising rates of cancer incidence and prevalence identified by the WHO are of serious concern. The scientific advances of the past twenty years have helped to describe major properties of the cancer disease, enabling therapies that are more sophisticated. It has become clear that the management of relevant risk factors can also significantly reduce cancer occurrence worldwide. Public health policy actions cannot be decoupled from environmental policy actions, since exposure to chemicals through air, soil, water and food can contribute to cancer as well as other chronic diseases. Furthermore, due to the increasing global trend of chemical production including novel compounds, chemical exposure patterns are foreseen to change, posing high demands on chemical safety assessment, and creating potential protection gaps. The safety assessment of carcinogenicity needs to evolve to keep pace with changes in the chemical environment and cancer epidemiology. The presentation focusses on EC-JRC recommendations and future strategies for carcinogenicity safety assessment. This also includes discussion on how the traditional data streams of regulatory toxicology, together with new available assessment methods can inform, along with indicators of public health status based on biomonitoring and clinical data, a more holistic human-relevant and impactful approach to carcinogenicity assessment and overall prevention of cancer disease.

Chemical safety assessment of transformation products of landfill leachate formed during the Fenton process

2021 ◽  
pp. 126438
Author(s):  
Luana de Morais e Silva ◽  
Vinicius M. Alves ◽  
Edilma R.B. Dantas ◽  
Luciana Scotti ◽  
Wilton Silva Lopes ◽  
...  
Keyword(s):  
Landfill Leachate ◽  
Safety Assessment ◽  
Transformation Products ◽  
Fenton Process ◽  
Chemical Safety

scholarly journals Toxicity testing: Non-animal approaches and safety science

2014 ◽  
Vol 36 (3) ◽  
pp. 19-25 ◽  
Author(s):  
Fiona Reynolds ◽  
Carl Westmoreland ◽  
Julia Fentem
Keyword(s):  
Safety Assessment ◽  
Toxicity Testing ◽  
Chemical Safety ◽  
Research Investment ◽  
Highly Sensitive ◽  
Safety Science ◽  
Modelling Techniques ◽  
Animal Tests ◽  
Made In

New informatics capabilities and computational and mathematical modelling techniques, used in combination with highly sensitive molecular biology and mechanistic chemistry approaches, are transforming the way in which we assess the safety of chemicals and products. In recent years, good progress has been made in replacing some of the animal tests required for regulatory purposes with methods using cells and tissues in vitro. Nevertheless, big scientific challenges remain in developing relevant non-animal models able to predict the effects of chemicals which are absorbed systemically. The greatest breakthroughs in non-animal approaches for chemical safety assessment will most likely result from continued multi-disciplinary research investment in predictive (integrative and systems) biology. Some of our current research in this area is described in the present article.

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