PK/TK Analysis
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.
In Vivo PK Studies
- Rank-ordering compounds/formulations
- 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
- Toxicokinetics
- 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)
Administration Routes and Collection
- Single agents, cassette dosing, single dose and repeat dose
- Dosing by PO, IV, IP, SC, etc.
- Serial sampling in all species
- Microsampling
- Tissue, urine and CSF collection
- Bile collections by bile duct cannulation (BDC)
- Fully integrated bioanalysis services
Surgical Models
- Bile duct cannulation
- Vascular access ports
- Portal vein cannulation
- Intestinal access ports