PK Analysis Services

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
• 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.