Regulatory toxicology and pharmacology : RTP
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“Cyclodextrin is frequently used in foods and cosmetics because it can change the physical properties of various compounds by their encapsulation within the cyclic structure. The average person is thought to ingest about 4 g of gamma-cyclodextrin per day from food. ... even people who have never received sugammadex may be sensitised by food and cosmetics.” (Mertes 2019)
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Regul. Toxicol. Pharmacol. · Feb 2019
ReviewLegal aspects of zebrafish neuropharmacology and neurotoxicology research.
Despite the growing emphasis on translational neuropharmacology and drug discovery research, the legality underlying these fields are seldom considered. The zebrafish (Danio rerio) is an increasingly utilized model organism in neuropharmacology and neurotoxicology. ⋯ Here, we discuss a wide range of regulatory topics relevant to zebrafish research, such as the bioethics of experimentation (including studies of stress and pain), welfare protection laws, the recent advances in CNS drug discovery, and specific legal aspects of controlled substance research in this aquatic species. The conceptualization and understanding of the zebrafish welfare and its promise as a model in toxicology can also potentially shape environmental protection practices and inform policy making.
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Regul. Toxicol. Pharmacol. · Apr 2019
ReviewShort commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products.
A range of generic valsartan products have been found to be contaminated with nitrosamines (principally N-nitrosodimethylamine; NDMA). We present information and discuss various elements of this phenomenon including: actions taken by regulatory agencies, source of the nitrosamine impurities, range of possible risk assessments based mainly on ICH M7 criteria, epidemiological assessment and analytical aspects.
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Regul. Toxicol. Pharmacol. · Feb 2018
Indoor air quality (IAQ) evaluation of a Novel Tobacco Vapor (NTV) product.
The impact of using a Novel Tobacco Vapor (NTV) product on indoor air quality (IAQ) was simulated using an environmentally-controlled chamber. Three environmental simulations were examined; two non-smoking areas (conference room and dining room) and one ventilated smoking area (smoking lounge). IAQ was evaluated by (i) measuring constituents in the mainstream NTV product emissions, (ii) and by determining classical environmental tobacco smoke (ETS) and representative air quality markers. ⋯ The concentrations of ammonia, carbonyls (formaldehyde, acetaldehyde, and acetone), and total volatile organic compounds were the same levels found in the chamber without NTV use. There was no significant increase in the levels of formaldehyde, acetone or ammonia in exhaled breath following NTV use. In summary, under the simulations tested, the NTV product had no measurable effect on the IAQ, in either non-smoking or smoking areas.
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Regul. Toxicol. Pharmacol. · Feb 2019
Assessment of the approved Risk Evaluation and Mitigation Strategy programs for New Drug Applications and Biologics Licensing Applications.
The Food and Drug Amendments Act of 2007, (FDAAA), granted the United States Food and Drug Administration to require drug manufacturers to develop a Risk Evaluation and Mitigation Strategy, (REMS). Implementation of the FDAAA required drug manufacturers to utilize risk minimization strategies beyond routine labeling for benefit-risk profiles of prescription drugs. The first full year of FDAAA implementation, 2008, through 2016, was reviewed to assess presence of differences in REMS requirements in Center for Drug Evaluation and Research (CDER) New Drug Applications, (NDAs), and Biologics License Applications, (BLAs). The risks present in the current unreleased approved REMS were reviewed to determine any difference in FDA requirements for safety risks identified in the NDA and BLA REMS programs.