Human biological relevance and the use of threshold-arguments in regulatory genotoxicity assessment: Experience with pharmaceuticals

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 464, Issue 1, 2000, Pages 19-34

  Müller, Lutz ^a   Kasper, Peter ^a  

^a Bundesinstitut Arzneimittel M   (Germany)

Author keywords

Genotoxicity; Pharmaceutical; Risk assessment; Threshold

Indexed keywords

ALKYLATING AGENT; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIVIRUS AGENT; BENZOQUINONE DERIVATIVE; CATECHOL DERIVATIVE; CYTOSTATIC AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DNA TOPOISOMERASE; DNA TOPOISOMERASE INHIBITOR; ESTERASE INHIBITOR; FLAVONOID; FOLIC ACID DERIVATIVE; GYRASE INHIBITOR; HERBACEOUS AGENT; HYPOXANTHINE PHOSPHORIBOSYLTRANSFERASE; NUCLEOSIDE DERIVATIVE; OPIATE; PACLITAXEL DERIVATIVE; PARACETAMOL; QUERCETIN; QUINOLINE DERIVED ANTIINFECTIVE AGENT; SALICYLIC ACID DERIVATIVE; VINCA ALKALOID;

AMES TEST; ANIMAL CELL; ANIMAL MODEL; BONE MARROW CELL; CARCINOGENIC ACTIVITY; CHROMOSOME ABERRATION; CONFERENCE PAPER; CONTROLLED STUDY; CYTOTOXICITY; DNA SYNTHESIS; DOSE RESPONSE; DRUG APPROVAL; DRUG SCREENING; EUROPEAN UNION; GENE MUTATION; GENOTOXICITY; HUMAN; HUMAN CELL; IN VITRO STUDY; INTERMETHOD COMPARISON; LYMPHOMA CELL LINE; MAXIMUM ALLOWABLE CONCENTRATION; MICRONUCLEUS TEST; MICROTUBULE ASSEMBLY; MOUSE; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RAT; RISK ASSESSMENT;

ANIMALS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; GERMANY; HUMANS; MUTAGENICITY TESTS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT;

ANIMALIA;

EID: 0342316476     PISSN: 13835718     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1383-5718(99)00163-1     Document Type: Article

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