clinical pharmacokinetics 

Efficiency of your pharmacokinetic (PK) data is vital to your program. As part of a full-service organization, our dedicated Pharmacokinetics group works closely with other operational departments to rapidly generate and report pharmacokinetic data for clinical trials in accordance with ICH E3 guidelines. We offer valuable input into study design, including important preclinical-to-clinical considerations (such as allometric scaling for the selection of the first-time dose in humans) utilizing information from preclinical studies. Employing industry-standard WinNonlin® software, we provide the following services:

• Non-compartmental analysis
• Compartmental pharmacokinetic analysis/simulations
• Assessment of dose proportionality
• Assessment of steady-state kinetics
• Bioavailability
• Drug-drug interaction analysis
• Special population PK analysis
• Pharmacodynamic (PD) and PK/PD modeling
• Deconvolution

You need advice and support for all aspects of clinical pharmacokinetics. We offer consultancy services as part of a complete development program, a full-service single-study package or a stand-alone service.

Our pharmacokineticists work closely with our data management, statistical and analytical staff at all stages of the study to ensure a smooth and effective transition of high-quality PK data.

For more information about our clinical pharmacokinetics services, contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.