R
R. DeWire
Researcher at Johnson & Johnson Pharmaceutical Research and Development
Publications - 1
Citations - 114
R. DeWire is an academic researcher from Johnson & Johnson Pharmaceutical Research and Development. The author has contributed to research in topics: Genotoxicity & Micronucleus test. The author has an hindex of 1, co-authored 1 publications receiving 88 citations.
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Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product
Gary Eichenbaum,Mark D. Johnson,David Kirkland,P. O’Neill,S. Stellar,J. Bielawne,R. DeWire,D. Areia,S. Bryant,S. Weiner,Daksha Desai-Krieger,P. Guzzie-Peck,David C. Evans,A. Tonelli +13 more
TL;DR: Results indicate that p-nitrophenol should be considered a non-genotoxic impurity and, as a drug impurity, a threshold limit of 4 mg/day would be set (per ICH Q3C).