Integrated strategies for assessment of metabolite exposure in humans during drug development: Analytical challenges and clinical development considerations

Biopharmaceutics and Drug Disposition

Volumn 30, Issue 4, 2009, Pages 163-184

  Zhu, Mingshe ^a   Zhang, Donglu ^a   Zhang, Haiying ^a   Shyu, Wen Chyi ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Metabolite; MIST; Safety monitoring; Strategy

Indexed keywords

BUSPIRONE; CARBON 14; DRUG METABOLITE;

AREA UNDER THE CURVE; ARTICLE; BLOOD LEVEL; DRUG ABSORPTION; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG EXPOSURE; DRUG LABELING; DRUG METABOLISM; DRUG MONITORING; DRUG TRANSFORMATION; HUMAN; INTERMETHOD COMPARISON; ION TRAP MASS SPECTROMETRY; ISOTOPE LABELING; LIQUID CHROMATOGRAPHY; LIQUID SCINTILLATION COUNTING; MASS SPECTROMETRY; METABOLITE; METABOLITE BLOOD LEVEL; NONHUMAN; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PATIENT SAFETY; PROTON NUCLEAR MAGNETIC RESONANCE; QUANTITATIVE ANALYSIS; RADIOACTIVITY; SENSITIVITY AND SPECIFICITY; ULTRAVIOLET RADIATION;

ANIMALS; BIOLOGICAL PRODUCTS; CHEMISTRY, ANALYTICAL; CHROMATOGRAPHY, LIQUID; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; DRUG MONITORING; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; MASS SPECTROMETRY; METABOLIC NETWORKS AND PATHWAYS; PHARMACEUTICAL PREPARATIONS; PLASMA; PRODUCT SURVEILLANCE, POSTMARKETING; REFERENCE STANDARDS; RISK ASSESSMENT; TISSUE DISTRIBUTION;

EID: 67849134950     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.659     Document Type: Article

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