Pharmacokinetics and Pharmacodynamics (PK/PD)
Critical data analysis. Maximize product value.
inVentiv Health Clinical offers expertise on designing quantitative toxicokinetic and PK/PD models, and interpreting results obtained from these models. In a nonclinical setting, allometric scaling can be used to model human exposure, adverse events, and clinical response for different doses or dosing regimens to help prepare your design of first-in-man studies.
In a clinical setting, knowledge gained from well-designed PK/PD (dose linearity, impact of demographic variables, effect of food, and drug interactions) and PD (adverse events profiles, biomarkers, QT prolongation, and early clinical efficacy) studies can help you optimize treatment regimens, improve the productivity and efficiency of your development program, increase confidence in strategic decisions, and maximize the commercial value of your product.
In Phase IIb and III studies, inVentiv Health Clinical pharmacometrics experts can utilize more advanced techniques for population PK analysis through medical and biostatistics modeling and biomarker and clinical outcomes simulations. We can provide assistance with PK/PD models of clinical studies for both branded and generic products.