Safety evaluation to support first-in-man investigations II: Toxicology studies

Regulatory Toxicology and Pharmacology

Volumn 51, Issue 2, 2008, Pages 237-243

  Baldrick, Paul ^a  

^a UK   (United Kingdom)

Author keywords

Genotoxicity; MTD; NOAEL; Non rodent; Repeat dose; Rodent; Single dose

Indexed keywords

ARTICLE; BACTERIAL MUTATION; BONE MARROW; CHROMOSOME ABERRATION; DOG; DOSE RESPONSE; DRUG QUALITY; DRUG SAFETY; GENOTOXICITY; HISTOPATHOLOGY; HUMAN; LIVER TOXICITY; MICRONUCLEUS TEST; MONKEY; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; QUALITY CONTROL; REVERTANT; RISK ASSESSMENT; RODENT; SINGLE DRUG DOSE; TARGET ORGAN; TOXICITY; TOXICOKINETICS; TOXICOLOGY;

ANIMALS; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; HUMANS; MUTAGENICITY TESTS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; TOXICITY TESTS;

CANIS FAMILIARIS; RATTUS; RODENTIA;

EID: 44649157645     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2008.04.006     Document Type: Article

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