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Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics
The consensus views of a cross-section of companies and organizations from the USA and Canada regarding the validation and application of liquid chromatography tandem mass spectrometry methods for bioanalysis of protein biotherapeutics in regulated studies are represented. Expand
Effective screening approach to select esterase inhibitors used for stabilizing ester-containing prodrugs analyzed by LC-MS/MS.
An effective approach was successfully developed to promptly select suitable esterase inhibitors for stabilizing ester-containing prodrugs through screening at three different plasma concentrations against an ester prodrug. Expand
Practical and efficient strategy for evaluating oral absolute bioavailability with an intravenous microdose of a stable isotopically-labeled drug using a selected reaction monitoring mass
This strategy significantly improves bioanalytical data quality and saves time, costs, and resources by avoiding a traditional absolute bioavailability study or the newer approach of microdoses of a radio-microtracer measured by accelerator mass spectrometry. Expand
Similar disposition, metabolism, pharmacokinetic, and protein covalent binding properties of 14C-labeled BMS-204352 were observed in humans, dogs, and rats. Expand
An exploratory universal LC-MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studies.
The novel exploratory LC-MS/MS assay reported herein, upon further refinement and full validation, is predicted to enable bioanalytical scientists to quantify all hinge region-stabilized human IgG4 therapeutic mAbs in human studies without having to develop a new assay for every new stabilized IgG 4 mAb entering clinical development. Expand
Cynomolgus Monkey as a Clinically Relevant Model to Study Transport Involving Renal Organic Cation Transporters: In Vitro and In Vivo Evaluation
The findings suggest that the cynomolgus monkey may have some utility in support of in vitro-in vivo extrapolations (IVIVEs) involving the inhibition of renal OCT2 and MATEs, which may inform human DDI risk assessment. Expand
Bioanalysis of dried saliva spot (DSS) samples using detergent-assisted sample extraction with UHPLC-MS/MS detection.
Dried saliva spot (DSS) sampling is a non-invasive sample collection technique for bioanalysis that can be potentially implemented at the patient's home without the need for clinical visits and detergent-assisted extraction with Triton-X-100 could be very useful in DSS or other dried matrix spot (DMS) assays to overcome low or inconsistent analyte recovery issues. Expand
A validated LC-MS/MS method for the simultaneous determination of BMS-791325, a hepatitis C virus NS5B RNA polymerase inhibitor, and its metabolite in plasma.
A rugged and accurate LC-MS/MS method was developed and validated for the quantitation of B MS-791325 and its metabolite, BMS-794712, in rat and dog plasma and was successfully applied to support pre-clinical toxicokinetic studies. Expand
Liquid chromatography and tandem mass spectrometry for the quantitative determination of ixabepilone (BMS-247550, Ixempra) in human plasma: method validation, overcoming curve splitting issues and
  • X. Xu, J. Zeng, +5 authors B. Stouffer
  • Chemistry, Medicine
  • Journal of chromatography. B, Analytical…
  • 15 February 2010
The method was demonstrated to be sensitive, selective and robust, and was successfully used to support clinical studies, and approaches used for resolving a curve splitting issue observed during quantitative analysis of ixabepilone in biological matrices were discussed. Expand
Determination of Real Time in Vivo Drug Receptor Occupancy for a Covalent Binding Drug as a Clinical Pharmacodynamic Biomarker by Immunocapture-LC-MS/MS.
A novel immunocapture (IC)-LC-MS/MS methodology to directly measure real time in vivo receptor occupancy (RO) for a covalent binding drug in blood lysate has been reported, demonstrating its suitability with high throughput for realTime in vivo BTK RO measurement as a pharmacodynamic (PD) biomarker for clinical drug development. Expand