Open Access. Powered by Scholars. Published by Universities.®
Pharmacology, Toxicology and Environmental Health Commons™
Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 1 of 1
Full-Text Articles in Pharmacology, Toxicology and Environmental Health
Development Of A Novel Method For Deriving Thresholds Of Toxicological Concern (Ttcs) For Vaccine Constituents, Jennifer Jessica White
Development Of A Novel Method For Deriving Thresholds Of Toxicological Concern (Ttcs) For Vaccine Constituents, Jennifer Jessica White
USF Tampa Graduate Theses and Dissertations
Abstract
Safety assessment relating to the presence of impurities, residual materials and contaminants in vaccines is a focus area of research at the United States Food and Drug Administration (FDA). Sponsors who submit Investigational New Drug (IND) applications for new vaccine products must report the results of safety assessments to the Division of Vaccines and Related Products Applications (DVRPA). Scientifically defining thresholds of toxicological concern (TTCs) as they apply to vaccine constituents will provide a useful aid to the sponsors and public regarding safety assessments of compounds for which there is little or no toxicity data. TTCs are mathematically modeled …