PK Studies

In vivo pharmacokinetic (PK) studies can be instrumental in the screening and selection of lead compounds with desirable bioavailability profiles for further investigation in drug development programs. Well-designed PK studies provide drug exposure data to assist in the study design and species selection of preclinical studies, including dosing schedule and dose levels. PK analysis prior to nonclinical toxicology studies verify that the formulation and dose form provides adequate drug exposure in the test animal.

IITRI offers a comprehensive solution for non-GLP PK studies that includes quick turnaround PK screening for lead optimization or formulation evaluation, and full PK programs that encompass the in-life study, bioanalysis and PK modeling. Studies can be conducted in rodents and nonrodents, including ferrets, dogs, mini pigs, and nonhuman primates (NHPs).

Bioanalysis is performed at our Chicago facility for determination of small molecules or biologics in blood, urine, plasma, serum, CSF, or tissues. Our state of the art bioanalytical capabilities include LC-MS/MS – AB SCIEX 5500 and robotic sample prep systems. Biologic drugs such as monoclonal antibodies (mAbs) may be determined using ELISA or qPCR assays.

PK Study Options

• Bioavailability
• Biodistribution and bioequivalence
• In vivo ADME
• PK/PD
• Studies using radiolabeled drugs

Routes of Administration

• Oral
• Subcutaneous
• Intravenous
• Continuous infusion
• Intramuscular
• Intraperitoneal
• Inhalation

Animal Models

• Rodents (mice, rats)
• Nonrodents (ferrets, guinea pigs, rabbits, canines, mini pigs
• Nonhuman primates (NHPs)

The IITRI Advantage

• Rapid turnaround from study initiation through generation of final report
• Highly experienced team of analytical chemists with more than 60% of the team holding advanced degrees
• Flexible, collaborative approach with customized study designs