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