PK Analysis | Pharmacokinetics and Pharmacodynamics

Quanticate has developed automated systems using the latest versions of Phoenix WinNonlin^® and 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
Compartmental PK modeling
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.

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.