In vivo ADME PK capabilities
- Bioanalytical method development and validation
- Highly flexible study design and readouts
- Formulation studies
- Highly flexible dosing routes
- Array of sampling techniques & matrices
- Determination of PK parameters (Phoenix WinNonLin software)
Discovery bioanalysis capabilities
Our bioanalytical service specializes in the quantification of test compound within in vivo samples from pharmacokinetic studies, enabling clients to access drug delivery mechanisms. We work to the highest industry standards and strict acceptance criteria to ensure our data is of the highest quality.
A robust 12-point matrix matched calibration curve is used to quantify compound in a wide range of biological matrices. Also included within the sample analysis are independent Quality Control (QC) samples. Typical extraction is performed via protein precipitation, other methods are available.
Analysis performed using state of the art LC-MSMS instrumentation, including Waters TQS Micro Xevo systems with next generation Acquity Premier Ultra High Performance Liquid Chromatography (UPLC) technology.
In addition to bioanalytical determinations, our labs also support biomarker assays and in vivo biotransformation. Concentration data is also further processed to provide pharmaco and toxicokinetic information using industry standard Phoenix WinNonLin software.
Our regulatory bioanalytical laboratories are GLP accredited and as such have the capability to develop and validate fully compliant methodologies in support of GLP TK studies.