Bioanalysis and DMPK Facility
The Pharmacokinetic Laboratory (PK lab) specializes in quantitative analyses of small molecule and potential anti-cancer agents and possible metabolites. We offer bioanalytical method development services and transfer under a non-GLP environment, with proper evaluation based on parameters according to FDA guidance (linearity, sensitivity, accuracy, stability and recovery) and depending on our client’s needs. Analyses are conducted in LC-MS/MS equipment using state of the art highly sensitive instrumentation (Waters Xevo TQ-S coupled with Acquity I-class UPLC system).
Within our 10,000 sq.ft. AAALAC-accredited vivarium, in vivo portion of relevant pharmacokinetic studies are conducted and samples easily transferred to our bio-analytical facility, ensuring integrated, robust and accurate sample analysis and results.
The PK lab provides dose guided therapeutic drug/dose adjustment as well as early screening and Proof of Concept (POC) for molecules of interest. Combining early chemistry with our POC xenograft models, we can provide alignment of compound kinetics from in vitro metabolism through PK and PD studies. Pharmacokinetic and toxicokinetic analysis is conducted using WinNonlin-Phoenix.
In vitro assays available are microsomal stability, hepatocyte stability, S9 stability, plasma stability and recombinant enzyme stability assays to determine the extent of metabolic stability in vitro. If required, preliminary metabolite profiling service is also available to provide general information regarding metabolites formed during the stability studies. We can perform microsomal binding studies to understand the free concentration available in the microsomal incubations.