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Hi, Are there any specific requirements on the quality of material with respect to endotoxin and bacterial contamination for the conduct of preclinical PK(-PD) studies with a Biologic?
In my opinion, the same (or lower) levels that have been deemed acceptable for in vivo efficacy and tox studies would make sense, and that otherwise the general rules for choice and use of animal models in efficacy studies apply?
Thanks for your help!
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