In Vivo Pharmacokinetics (PK)
Sygnature’s integrated and seamless approach to drug discovery combines our in-house expertise in in vivo pharmacology, offering a continuous oversight from study initiation to completion, thereby enhancing the likelihood and pace of achieving 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.
Sample analysis includes a robust calibration curve comprising a minimum of 8 calibration standards, supplemented by independent Quality Control (QC) samples. Furthermore, the study design can incorporate the analysis of dose formulation concentrations.
The resultant data is condensed into a concise summary spreadsheet, featuring pertinent pharmacokinetics parameters as needed.
In the realm of In Vivo Pharmacokinetics (PK):
In vivo pharmacokinetic reports encompass the entirety of raw data, computations, and a summary table encapsulating calculated parameters. This includes key metrics such as clearance, volume of distribution, AUC, half-life (T1/2), Cmax, Tmax and bioavailability. These calculations adhere to industry norms, utilising WinNonLin or equivalent software for NCA and PK/PD modelling and simulation.
Sygnature is deeply committed to championing the principles of the 3Rs – Replacement, Reduction, and Refinement – in our scientific endeavours.