Pharmacokinetics

Preclinical Contract Pharmacokinetics (PK) Study Services

Call us at 408.738.9260

Comparative Biosciences, Inc. (CBI), a preclinical Pharmacokinetics (PK) CRO, offers a complete range of research services in the area of pharmacokinetic, toxicokinetic, bioavailability, and ADME studies for small molecules, large molecules, biologics (vaccines, antibodies, proteins, botulinum toxin, viral, stem cells, radiolabeled products), and other related test articles and devices. Animal species for these studies include mice, rats, guinea pigs, hamsters, gerbils, ferrets, dogs, cats, and pigs (juvenile or adult), as well as in disease models, by standard and unusual or specialized routes of administration.

We feature rapid study initiation and report preparation to meet sponsor deadlines or milestones. We comply with FDA, OECD, and ICH guidelines. Our capabilities in Pharmacokinetics include early exploratory, investigative, or screening studies, cassette dosing studies, juvenile studies, disease model studies, and formal studies that support regulatory submission.

Delivery Methods

  • Single-dose, multiple-dose, or continuous or slow infusion
  • Routes: all routes, including unusual routes
  • High-throughput Cassette Screening--up to 5 compounds administered simultaneously
  • Sampling: blood, urine, feces, vitreous, aqueous, cerebrospinal fluid, bile, semen, saliva, joint fluid, other.
  • Tissue or organ collection and analysis
  • PCR tissue collection

Animal Species

  • Mice
  • Immunocompromized mice and rats
  • Rats
  • Cotton rats
  • Guinea pigs
  • Chinchillas
  • Gerbils
  • Hamsters
  • Ferrets
  • Pigs
  • Juvenile pigs
  • Dogs
  • Diseased animals/animal models/tumor models

Routes of administration

  • routine systemic,
  • dermal/topical
  • ocular (topical, intraocular)
  • infusion
  • depot
  • mechanical or osmodic pumps
  • intra-arterial
  • intranasal
  • intracerebral (stereotaxic)
  • intrathecal
  • intra-tracheal
  • intra-intestinal
  • intra-rectal
  • intravaginal
  • intravesicular
  • other unusual routes

Pharmacokinetic Studies in Disease Models

Disease states can alter the metabolism of some test articles. Consequently, pharmacokinetic assessments in disease models may be important. CBI provides custom pharmacokinetic studies in all the animal models and tumor models that CBI offers.

Large Animal PK Studies

CBI maintains a standing colony of healthy dogs and pigs for use in PK studies for our clients. Alternatively, CBI can also maintain dedicated colonies of dogs or pigs specifically for individual sponsors. Dedicated colonies assure the sponsor that PK studies can be scheduled and conducted very rapidly, usually with a 1-2 week turn around between scheduling and delivery of specimens for analytical assessment.