Non-clinical Subacute Toxicity Study of PET Radiotracer for eIND FDA Testing
Project Description
FDA cGLP Contract Research Organization (CRO) needed for Non-clinical subacute toxicity study of positron emission tomography (PET) radiotracer to support Emergency Investigational New Drug (eIND) submission to FDA.
Single and daily for five days iv administration of vehicle or tracer compound at 100 and 500 times the expected human dose (100 micrograms for PET tracers) to groups of ten rats, with daily assessment of behavior, body weight, food consumption, as well as hematology, clinical chemistries, and necropsies (macroscopic and histopathology) on days three and fifteen (cf. FDA Guidance for Industry, Investigators, and Reviewers - Exploratory IND Studies, January 2006 and FDA Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, January 2010)
Project Information
Number:23-01061
Industry:Medical Research
