Core #2 Preclinical testing Milton V. Marshall, Ph.D. DABT The preclinical core will provide services to the NTR program to develop safety and toxicity profiles of candidate imaging agents. Facilities are available in our satellite facility at BCM to house rodents for safety and toxicity testing of molecular imaging agents. Should larger animals be needed, additional space is available through the BCM Center for Comparative Medicine (CCM). CCM personnel who work on GLP studies have received training in Good Laboratory Practices, and some personnel have previous work experience in a GLP facility. Thus, facilities and personnel are available to conduct GLP-compliant preclinical safety and toxicity studies as needed under this program. Dr. Marshall has experience in drug development using different animal models, including rodents, dogs, and primates;his work in preclinical medical device development includes use of farm animals (sheep, pigs, and calves). Brian Gibson, DVM, will work with Dr. Marshall in study design and in monitoring the health of animals on safety studies. Because BCM does not maintain a GLP-compliant clinical chemistry and hematology laboratory, samples will be sent to a local GLPcompliant facility, Equine Laboratories. Likewise, histopathology will be conducted at a GLP-compliant facility, and slides will be reviewed by a board-certified Veterinary Pathologist with experience in preclinical drug and device development.
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