Meeting report: Metabolites in safety testing (MIST) symposium - Safety assessment of human metabolites: What's REALLY necessary to ascertain exposure coverage in safety tests?

AAPS Journal

Volumn 15, Issue 4, 2013, Pages 970-973

  Gao, Hongying ^a   Jacobs, Abigail ^b   White, Ronald E ^c   Booth, Brian P ^b   Obach, R Scott ^a  

^a PFIZER INC   (United States)

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

^c XENOBIOTIC LABORATORIES INC   (United States)

Author keywords

ICH M3(R2); LC MS MS; metabolite exposure coverage in safety test; MIST; safety assessment of human metabolites

Indexed keywords

DRUG METABOLITE;

CONFERENCE PAPER; DRUG DOSE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; ISOTOPE LABELING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MATERIAL STATE; NONHUMAN; PRACTICE GUIDELINE; SYMPOSIUM; TOXICITY TESTING;

ANIMALS; CHICAGO; DRUG EVALUATION, PRECLINICAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; PHARMACEUTICAL PREPARATIONS; SPECIES SPECIFICITY;

EID: 84887998723     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9502-6     Document Type: Conference Paper

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