In vivo ADME and PK studies

CLS-logo.png We offer a rapid Non-GLP discovery rodent in vivo ADME pharmacokinetics (PK) and bioanalysis. We engage with clients to help design the most appropriate study format tailored to our clients' requirements. In-life phases are delivered through our trusted partners and the samples are then returned to Concept Life Sciences for full bioanalysis.

Our CRO services place a high value on client communication during all phases of a study. We engage with clients at each stage of the process to deliver high quality and timely data whether it be a discovery-phase screen or a complex and unique in vivo study.

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. 

Learn more about discovery bioanalysis.

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.