Assessment of the genotoxic and carcinogenic risks of p-nitrophenol when it is present as an impurity in a drug product

Regulatory Toxicology and Pharmacology

Volumn 55, Issue 1, 2009, Pages 33-42

  Eichenbaum, G ^a   Johnson, M ^a   Kirkland, D ^b   O'Neill, P ^a   Stellar, S ^a   Bielawne, J ^a   DeWire, R ^a   Areia, D ^a   Bryant, S ^a   Weiner, S ^a   Desai Krieger, D ^a   Guzzie Peck, P ^a   Evans, David C ^a   Tonelli, A ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b UK   (United Kingdom)

Author keywords

Carcinogenicity; Drug product; Exposure; Genotoxicity; Hazard identification; Impurity; Nitrophenol; p Nitrophenol; Paranitrophenol

Indexed keywords

4 NITROPHENOL;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CARCINOGENICITY; CONTROLLED STUDY; DRUG IMPURITY; FEMALE; GENOTOXICITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MAXIMUM ALLOWABLE CONCENTRATION; MICRONUCLEUS; MOUSE; NONHUMAN; PRIORITY JOURNAL; SKIN ABSORPTION; TOXICOKINETICS;

ANIMALS; CARCINOGENS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG CONTAMINATION; ENVIRONMENTAL EXPOSURE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MICE; MICRONUCLEUS TESTS; MUTAGENS; NITROPHENOLS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; SKIN; THRESHOLD LIMIT VALUES;

MAMMALIA;

EID: 69049101011     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.05.018     Document Type: Article

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