Next generation safety assessment strategy based on combined use of in silico tools

Having role in gene regulation and silencing, miRNAs have been implicated in development and progression of a number of diseases, including cancer. Herein, I present potential miRNAs associated with BAP1 gene identified using in-silico tools such as TargetScan and Exiqon miRNA Target Prediction. I identified fifteen highly conserved miRNA (hsa-miR-423-5p, hsa-miR-3184-5p, hsa-miR-4319, hsa-miR125b-5p, hsa-miR-125a-5p, hsa-miR-6893-3p, hsa-miR-200b-3p, hsa-miR-200c-3p, hsa-miR-505-3p.1, hsa-miR-429, hsa-miR-370-3p, hsa-miR-125a-5p, hsa-miR-141-3p, hsa-miR-200a-3p, and hsa-miR-429) associated with BAP1 gene. We also predicted the differential regulation of these twelve miRNAs in different cancer types.

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Faculty Opinions recommendation of Do common in silico tools predict the clinical consequences of amino-acid substitutions in the CFTR gene?

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3352957.3050059 ◽

2010 ◽

Author(s):

Stephen Scherer ◽

Richard Wintle

Keyword(s):

Amino Acid ◽

In Silico ◽

Cftr Gene ◽

Amino Acid Substitutions ◽

Clinical Consequences ◽

In Silico Tools

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An Update of In Silico Tools for the Prediction of Pathogenesis in Missense Variants

Current Bioinformatics ◽

10.2174/1574893611106020185 ◽

2011 ◽

Vol 6 (2) ◽

pp. 185-198

Author(s):

Alejandro j. Brea-Fernandez ◽

Marta Ferro ◽

Ceres Fernandez-Rozadilla ◽

Ana Blanco ◽

Laura Fachal ◽

...

Keyword(s):

In Silico ◽

Missense Variants ◽

In Silico Tools

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

Nutrients ◽

10.3390/nu13030733 ◽

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.

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