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Metabolism and Disposition of a Novel B-Cell Lymphoma-2 Inhibitor Venetoclax in Humans and Characterization of Its Unusual Metabolites
- Hong Liu, Melissa J. Michmerhuizen, Anthony J. Lee
- ChemistryDrug Metabolism And Disposition
- 1 March 2017
Steady-state plasma concentrations of M27 in human and preclinical species used for safety testing suggested that M27 is a disproportionate human metabolite, which is not expected to have clinically relevant on- or off-target pharmacologic activities.
ABT‐335, the Choline Salt of Fenofibric Acid, Does Not Have a Clinically Significant Pharmacokinetic Interaction With Rosuvastatin in Humans
Results from this study demonstrate no clinically significant pharmacokinetic interaction between ABT‐335 at the full clinical dose and rosuvastatin at the highest approved dose.
Toxicokinetic evaluation of atrasentan in mice utilizing serial microsampling: validation and sample analysis in GLP study.
Good quality exposure data were obtained from every serial sampled mouse in the study and excellent assay reproducibility was demonstrated where 100% of samples met incurred sample reanalysis acceptance criteria.
Quantitative Determination of ABT-925 in Human Plasma by On-Line SPE and LC-MS/MS: Validation and Sample Analysis in Phase II Studies
A fully automated 96-well On-Line Solid Phase Extraction (SPE) followed by High Performance Liquid Chromatography (HPLC)-Tandem Mass Spectrometric (MS/MS) method for the determination of ABT-925 in human plasma was developed, validated and utilized in Phase II clinical studies.