Predicting Circulating Human Metabolites: How Good Are We?

The FDA issued a guidance on the safety testing of metabolites in February 2008, in which they stated that metabolites of concern are those that are detected at levels greater than 10% of the systemic exposure of the parent at steady state. This has presented many challenges in determining the circu...

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Veröffentlicht in:	Chemical research in toxicology 2009-02, Vol.22 (2), p.243-256
Hauptverfasser:	Anderson, Shelby, Luffer-Atlas, Debra, Knadler, Mary Pat
Format:	Artikel
Sprache:	eng
Schlagworte:	Carbon Radioisotopes Chromatography, High Pressure Liquid Drug Evaluation, Preclinical - methods Guidelines as Topic Humans Mass Spectrometry Metabolic Networks and Pathways Models, Animal Pharmaceutical Preparations - blood Pharmaceutical Preparations - metabolism Predictive Value of Tests
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