Toxicology and Risk Assessment

The risk assessment is based on a chemical characterization of the test article, published information from the toxicological literature, and tolerable exposure limits, which may be adopted from published guidelines or derived on the basis of available toxicology data. The objective of a toxicological risk assessment is to evaluate the potential health risks associated with exposure to leachable impurities, contaminants, or other residues in a medical device or drug product. Based on the data from a chemical characterization, the risk assessment is to make a determination as to whether the release of chemicals during the use of a medical device or drug formulation may represent a toxicological risk that is unacceptable from a regulatory perspective. TRA is a research-based evaluation comprised of four activities: Hazard identification and data evaluation; Exposure assessment; Dose-response analysis; Risk characterization.



For more: http://www.globalepisteme.org/Conference/toxicology-pharmacology-conference/

Submit your abstract: http://www.globalepisteme.org/Conference/toxicology-pharmacology-conference/submitabstract


Contact us: toxicology@globalepisteme.com

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