Helping clients determine dosage levels for drug efficacy studies
Syngene offers pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation expertise across a wide array of techniques and applications to helps clients select the appropriate dosage levels for efficacy studies. Using both science and art, we help clients choose an accurate model that provides insights into the pharmacokinetic parameters of a compound, and aid in the interpretation of dose-response and dose escalation studies during early clinical testing. Our models avoid bias, justify the goodness of fit, diagnostic, and graphical criteria, and help with accurate and precise prediction of pharmacokinetic parameters.
Our expert services provide a robust and effective way to characterize observed data and provide a strong foundation to simulate efficacy study designs. They include:
- PK/PD/ efficacy correlations based on exposure or Cmax
- PK modeling and simulations
- Scaling of preclinical PK to predict human PK using allometry approach
- Prediction of first-in-human (FIH) and median efficacious doses (MED)
- Pharmacokinetic parameter evaluations using Phoenix WinNonlin