ICH M3(R2): IND 및NDA를위한비임상안전성시험

1 rodent & 1 non-rodent Relevant species 1 rodent & (1 non-rodent)* Endpoint Toxicological endpoint Exaggerated pharmacological effect Toxicological endpoint Limit dose 1000 mg/kg Max PD dose 2000 mg/kg Exposure limit 50X 10X - Bioanalysis TK TK, Ab, (nAB) (Index compound TK) *한약(생약)제제비임상시험가이드라인(MFDS 2014.11.):

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