PK/PD Modelling Services

Quanticate has developed automated systems using the latest versions of Phoenix WinNonlin® and SAS® to deliver high quality PK reports, along with additional PK, pharmacodynamic (PD) and PK/PD services, including:

Input into study design, including sample size estimation and optimisation of PK sampling.
Non-compartmental and compartmental PK modelling.
Statistical analyses including bioequivalence, bioavailability, food-effect, drug-drug interactions, dose-proportionality and special populations.
PD analyses using various graphical and statistical approaches.
PK/PD non-linear and non-linear mixed modelling techniques.
Fast-turn around interim PK analyses in support of first-time-in-man studies.
Simulation to help predict systemic exposure (and PD effects) for alternative dosing regimens.
GCP certified, with all work performed in accordance with relevant ICH, EMEA and FDA guidelines.

One of the main reasons for drug attrition in clinical development is poor pharmacokinetics (PK) [Kola and J. Landis, Nature Reviews Drug Discovery, 3, 711-715 (2004)]. To reduce this risk, it is essential to fully investigate the pharmacokinetics of a new drug during each stage of development.