pharmacokinetic studiesPharmacodynamic capabilities

Pharmacokinetics is one of the most important aspects of drug discovery and development process.  It is key to selecting early compounds or chemical structures for further assessment.  CBI offers a range of pharmacokinetic and pharmacodynamic capabilities across a broad spectrum of indications that ensure reliable results in the drug-discovery process.  Assessment and analysis modalities are fine-tuned to meet the specific requirements demanded in each targeted area of scientific investigation.

Screening Pharmacokinetic Studies

  • Quick, inexpensive, “mini-PK” studies (compound sparing for rapid assessment of new molecules in rodents)
  • Routine single or multiple dose pharmacokinetic studies
  • Oral, ocular, dermal, intra-tracheal, IV, IM, SC, IP, joint fluid, short-infusion and other routes of administration including intracranial by stereotaxic injection or infusion
  • Small molecules, proteins, antibodies, biologics, scheduled compounds
  • Radionuclide studies

intracranial dosingPharmacokinetic Studies

  • Research and GLP IND enabling pharmacokinetic studies
  • Protocol driven, with complete and comprehensive reports
  • Pharmacodynamic endpoints also available
  • Wide range of species including rodents, rabbits, hamsters, guinea pigs, ferrets, dogs and mini-pigs
  • Single dose or multiple dose studies of short or long duration
  • Oral, ocular, dermal, intra-tracheal, IV, IM, SC, IP, joint fluid, short-infusion and other routes of administration including intracranial by stereotaxic injection or infusion
  • Pharmacokinetic-pharmacodynamic studies in disease models such as tumor-bearing animals, infection models, inflammation models, metabolic diseases, and surgical models
  • Small molecules, proteins, antibodies, biologics, scheduled compounds
  • Radionuclide studies

Dog Pharmacokinetic Studies

  • CBI maintains a colony of male and female Beagles as dedicated pharmacokinetic dogs
  • Mini PK, research and GLP/IND enabling pharmacokinetic studies
  • Clients may choose to use colony dogs or CBI may also maintain dogs exclusively dedicated to a particular client
  • Large dogs are also available by request

Ocular Pharmacokinetics

  • CBI specializes in ocular pharmacokinetics in multiple species
  • Systemic, topical to intact or injured cornea, or intravitreal administration
  • Corneal injury models including the hepatanol-induced corneal erosion model
  • Single or multiple administration of test article
  • Collection of blood, urine, aqueous humor, vitreous fluid in vivo on multiple occasions during the course of the study
  • Collection of entire eye, or subparts such as retina, choroid, lens, cornea post mortem
  • Small molecules, proteins, antibodies, biologics, scheduled compounds
  • Radionuclide studies
  • High quality, rapid reports

Pharmacokinetic Studies Include

  • Experienced, highly trained study directors
  • Senior staff with extensive experience in pharmacokinetics
  • Complete and comprehensive documentation and report preparation including analysis with “PK Solutions™” software upon request
  • Pathology and clinical chemistry reviewed and interpreted by board-certified pathologist

Analytical Methods

  • CBI provides analytical method development and bioanalytical determinations to support pharmacokinetic studies, including unusual matrices such as eye or joint.
  • HPLC, MS, LCMS
  • Complete and comprehensive documentation and report preparation including analysis with “PK Solutions™” software

Top