Understanding the pharmacokinetics (PK) of a test article is an essential component of drug discovery and development programs. At Charles River, we are able to support rapid bioavailability screening during drug candidate design and selection as well as define the PK profile of compounds in the development phase.
Rapid PK Screening
The iterative nature of in vivo PK screening requires rapid cycle times with changing priorities. We have built a team of experienced scientists with facilities and processes designed specifically to meet these challenging requirements. When combined with our discovery bioanalysis, Charles River provides you with standard PK parameters for non-compartmental analysis within five days of dosing.
From standard screening to more complex studies, our team of experienced study directors can also assist in designing the best strategy and protocols customized to suit any drug discovery program. Rapid study initiations facilitated by our maintenance supply of rodents and colonies of non-rodent species along with standardized protocols and fully integrated LC-MS/MS bioanalysis of PK samples, including small volume samples, result in better data faster.
Experienced scientists within Charles River design and conduct PK studies to examine multiple parameters in support of regulatory submissions using radiolabeled or nonradiolabeled test articles with a range of analytical support, including radioassay, LC-MS/MS, HPLC, CE or immunochemistry. Toxicokinetic assessments can be conducted in parallel or concurrent with ongoing toxicology programs and in compliance with GLP requirements.
Bioavailability and bioequivalence
Dose proportionality (ascending dose)
- Dose linearity (multiple dose)
- Drug-drug interactions
- Special populations
- Tissue distribution (non-radioactive and radioactive)
- Blood brain barrier
- Anti-drug antibodies
- Non-compartmental and compartmental pharmacokinetics
- Pharmacodynamic and pharmacokinetic/pharmacodynamics modeling
- Input into study design, including preclinical-to-clinical considerations (allometric scaling and human equivalent dose projections)