In Vivo Pharmacokinetics (PK)
Sygnature’s integrated and seamless approach to drug discovery includes our in-house in vivo pharmacology capabilities and expertise. This enables us to track a study from start to finish, increasing the chances and speed of success.
At Sygnature we offer services to support your non-GLP in vivo pharmacokinetics studies in preclinical rodent species, including the planning of these studies and the analysis of any samples generated by UPLC-MS.
A calibration curve with a minimum of 8 calibration standards and independent Quality Control (QC) samples are included in sample analysis. The analysis of dose formulation concentrations can also be incorporated into the study design.
All data generated is shared in a summary spreadsheet which includes calculated PK parameters where required.
In vivo pharmacokinetic reports include all raw data, calculations and a summary table with calculated paraments and notes highlighting any suggestions or issues encountered. All typical PK parameters such as clearance, volume of distribution, AUC, half-life (T1/2), Cmax, Tmax and bioavailability are calculated using WinNonLin or equivalent software, following the industry standard for NCA and PK/PD modelling and simulation.
Sygnature is committed to supporting the 3Rs.