Obtaining Exposures of Metabolites in Preclinical Species through Plasma Pooling and Quantitative NMR: Addressing Metabolites in Safety Testing (MIST) Guidance without Using Radiolabeled Compounds and Chemically Synthesized Metabolite Standards
Author:
Affiliation:
1. Biotransformation, Drug Safety and Metabolism, Wyeth Research, 500 Arcola Road, Collegeville, Pennsylvania 19426
Publisher
American Chemical Society (ACS)
Subject
Toxicology,General Medicine
Link
https://pubs.acs.org/doi/pdf/10.1021/tx8003328
Reference28 articles.
1. A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection
2. Nuclear Magnetic Resonance Spectroscopy as a Quantitative Tool To Determine the Concentrations of Biologically Produced Metabolites: Implications in Metabolites in Safety Testing
3. Determination of mean valproic acid serum level by assay of a single pooled sample
4. Pooling plasmas for a rapid answer in pharmacokinetic studies: application to a bioequivalence study of hydrocortisone tablets
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