Bioanalysis and DMPK Facility
Assess quantitative analyses of small and large molecules—and possible metabolites—through our Pharmacokinetic Laboratory (PK lab), which offers:
- Bioanalytical method development and transfer under a non-GLP environment, with proper evaluation based on FDA guidance parameters (linearity, sensitivity, accuracy, stability and recovery)
- Highly-sensitive instrumentation that conducts analyses via LC-MS/MS equipment (Waters Xevo TQ-S coupled with Acquity I-class UPLC system)
The DMPK Lab
Have every confidence that your sample analyses and results are protected, robust and accurate. From there, in vivo portions of pharmacokinetic studies are conducted and then easily transferred to our co-located bioanalytical facility.
Exclusive features now available:
- Therapeutic Drug and Dose Adjustment: Access dose-guided therapeutic drug and dose adjustment, as well as early screening and Proof of Concepts (POC) for small and large molecules of interest.
- Compound Kinetics: Combining early chemistry with POC xenograft models, we provide alignment of compound kinetics from in vitro metabolism through PK and PD studies.
- Expert Research Analysis: Our oncology research experts conduct pharmacokinetic and toxicokinetic analysis through the Phoenix WinNonlin.
In vitro assays now available:
- Microsomal stability
- Hepatocyte stability
- S9 stability
- Plasma stability
- Recombinant enzyme stability assays (determine the extent of metabolic stability in vitro)
- Caco-2 permeability
- Time-dependent inhibition
Need More Analysis?
Should you need additional insights regarding metabolites formed during the stability studies, we offer a preliminary metabolite profiling service, and can perform microsomal binding studies to understand the free concentration available in the microsomal incubations.