There is often a need for specialized and complex toxicology studies, generally to address unanticipated or unusual toxicologic events or to conduct toxicology studies that are of a difficult or unusual nature. These investigative, custom, and special toxicology studies are directed, hypothesis-driven, and may have specialized or unusual techniques or methods. In some cases, such studies are requested by the FDA or by clinicians. Examples might include CT or PET scanning, DEXA, specialized immunohistochemistry, surgical aspects, application of test article surgically, esoteric blood samples, or characterizing an unexpected toxicity. The skilled scientists at CBI can facilitate the protocol development as well as the conduct of these difficult and specialized projects.
Do you have a special toxicity study or special problem or an unusual surgical toxicology study? CBI can help!
There is often a need for specialized and complex toxicology studies, generally to address unanticipated or unusual toxicologic or pharmacological events or to conduct tolerability, efficacy or pharmacology studies that are of a novel, difficult or unusual nature. These studies are directed, hypothesis driven, and may have specialized or unusual techniques or methods. In some cases they are requested by the FDA or by clinicians. If you have such a problem, the skilled scientists at CBI can facilitate the protocol development as well as the conduct of these novel, difficult and specialized projects.
CBI has conducted numerous such custom GLP studies with examples including
- Stem cell toxicity-efficacy-device toxicity studies
- Intrathecal dosing toxicity studies in dogs and rodent
- Anesthesia-induced cerebral toxicity in neonates
- Stereotaxic and intracerebral administration of chemotherapeutic in rodents and dogs
- VX2 tumor combination toxicity and efficacy studies in rabbits
- Wound healing and burn combination toxicity and efficacy studies
CT scan, dog with intracerebral dosing of chemotherapeutic agent. Note lesion on left side of skull.
Intrathecal Dosing Studies
CBI provides highly specialized administration of chemotherapeutics, analgesics, or other therapeutic agents intrathecally by single dose or infusion via intrathecal catheterization to small animals or dogs. CBI provides this highly specialized model in collaboration with Maccine, LLC, in cynomolgus monkeys as well. The activity, tolerability and pharmacokinetics of test articles may be determined in either a GLP or nonGLP environment and may include assessments such as clinical neurologic parameters, clinical pathology, toxicokinetics, CT scanning, PCR, CSF analysis, and complete histopathology and immunohistochemistry.
For more information, contact CBI
Anesthesia-induced Cerebral Toxicity in Neonates
Anesthetic agents may induce neuroapoptosis and other types of cerebral toxicity in fetuses and neonates. CBI provides this highly specialized model of anesthesia toxicity in rodents and in collaboration with Maccine, LLC, in cynomolgus monkeys. Brains from treated fetuses are extensively examined using immunohistochemistry and histomorphometry to assess the extent of neuroapotosis. Photomicrographs demonstrating ketamine-induced neuroapoptosis and a normal fetal brain are presented.