Pharmacokinetics and Pharmacodynamics

GK ANALYTICS has developed automated systems using the latest versions of SAS ® to deliver high quality pharmacokinetic (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 PK modeling
● Fast turnaround interim PK analyses in support of first-time-in-man studies
● Input into Clinical Study Reports
● Statistical analyses including bioequivalence, bioavailability, food-effect, drug-drug interactions, dose-proportionality and special populations
● PK Handover Document Production
● PD analyses using various graphical and statistical approaches
● PK/PD linear and non-linear mixed modeling techniques
● Simulation to help predict systemic exposure (and PD effects) for alternative dosing regimens
All work is performed in accordance with relevant GCP, ICH, EMEA, and FDA guidelines. .