Preclinical Pharmacokinetic Studies

CBI provides a complete range of research services related to preclinical pharmacokinetic, toxicokinetic, bioavailability, bioequivalence and ADME studies.

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. We specialize in unusual and customized studies and custom pharmacokinetic studies in all species of research models. Our large colonies enable us to schedule and conduct studies very rapidly, usually within a one- to two-week period from scheduling to the delivery of specimens for analytical assessment.

Delivery Methods

  • High-throughput cassette screening, up to 5 compounds administered simultaneously
  • PCR tissue collection
  • Routes: all routes, including unusual routes
  • Sampling:
    • Aqueous humor
    • Bile
    • Blood
    • Cerebrospinal fluid
    • Feces
    • Joint fluid
    • Semen
    • Saliva
    • Otic perilymph
    • Urine
    • Vitreous
    • Other tissues or fluids
  • Single dose, multiple dose, continuous or slow infusion
  • Tissue or organ collection and analysis

Routes of Administration

  • Dermal/topical
  • Infusion
  • Depot
  • Intra-arterial
  • Intra-articular or bone
  • Intra-intestinal
  • Intrarectal
  • Intratracheal
  • Intracerebral (stereotaxic)
  • Intranasal
  • Intrathecal
  • Intravaginal
  • Intravesicular
  • Mechanical or osmodic pumps
  • Ocular (topical, intra-ocular, periocular)
  • Otic, external and inner ear
  • Routine systemic
  • Surgical routes
  • Other unusual routes

Preclinical Veterinary Studies

Comparative Biosciences Inc., a premier veterinary preclinical contract research organization, is committed to providing expert high-quality contract research services to the veterinary and animal health industry. Extensive experience industry provides our staff with a solid track record in preclinical veterinary research and drug development capabilities. We work closely with both sponsors and Veterinary Clinical Research Organizations to support studies that are needed to support regulatory submissions to the USDA and FDA.

We offer toxicology, pharmacokinetic and pharmacology studies in all relevant veterinary species (juvenile and adult). We offer a wide range of routes of administration as well as unusual and specialized routes of administration for a wide variety of test articles including small molecules, large molecules, biologics (vaccines, antibodies, proteins, toxins, viral, stem cells, radiolabeled products), and other related test articles and devices.

Larger Species and Colony Studies

CBI maintains a standing colony of larger species for use in PK studies for our clients. Alternatively, CBI can also maintain dedicated colonies specifically for individual sponsors.