Biologics vs Standard Toxicology

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JRod0311's picture
Biologics vs Standard Toxicology

These days you can't work in research without running into Biologics and Novel Therapuetics.  Many Labs that used to exclusively conduct small molecule Tox studies are now finding themselves running more and more Biologics studies, usually on the same standard animals as before (Mouse, Rat, Dog and Monkeys).  There are new guidances and standards being created on what to do as a PI for the types of studies you need to conduct for INDs but there is little to no liturature out there on changes (if any) that should take place in vivarium. 

Does anyone know of any differences in the conduct of pre-clinical studies for Biologics Tox and Pharma studies vs what is done in conventional small molecule Tox studies.  Thsi covers:

Formulation of Test Article
Dose Administartion
Handling and Husbandry
Any additional or less steps for the prevention of cross contamination

Thanks ahead of time for any insight