Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.

Regulatory Toxicology and Pharmacology

Volumn 56, Issue 1, 2010, Pages 1-3

  Wu, Kuei Meng ^a   Dou, Jinhui ^a   Ghantous, Hanan ^a   Chen, Shaw ^a   Bigger, Anita ^a   Birnkrant, Debra ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Botanical drugs; Genotoxicity; Herbals; Regulatory toxicology

Indexed keywords

HERBACEOUS AGENT; PLANT MEDICINAL PRODUCT;

COST EFFECTIVENESS ANALYSIS; DIET SUPPLEMENTATION; DRUG APPROVAL; DRUG SAFETY; GENOTOXICITY; GOVERNMENT REGULATION; NOTE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REPRODUCIBILITY; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MUTAGENICITY TESTS; PLANT PREPARATIONS; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES;

EID: 75549085963     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2009.09.012     Document Type: Note

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