INITIAL INVESTIGATIONAL NEW DRUG APPLICATION
Aug 01, 2019 · Are GLP animal tox. icity studies performed in . China. acceptable to the Agency? We plan to submit . IND. for the Drug XY (or biologic) and a separate . IND. ... is a formal animal toxicology study necessary? We propose to perform a 5-dose infusion toxicity study in rabbits. Is this study acceptable to support the 5-dose initial Phase I ... ................
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