In Vivo Pharmacokinetics
At Sygnature Discovery we offer services to support your non-GLP in vivo Pharmacokinetics studies in preclinical species including the planning of these studies and the analysis of any samples generated by UPLC-MS.
Following storage of samples at either -20 °C or -80 °C, samples will be prepared and then analysed. A calibration curve with a minimum of 8 calibration standards and independent Quality Control (QC) samples are included. The analysis of dose formulation concentrations is included where required as part of our service.
All data generated will be 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 Modeling and Simulation.