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ICH M3(R2): IND 및NDA를위한비임상안전성시험
Pharmacokinetics Analytical Method andValidation Accuracy, precision,selectivity, ... Species 2 1 Route Clinical & parenteralroute Clinical route GLP GLP Non-GLP Timeline Priorto P1 Prior to P3 ... (MFDS 2014.11.): 충분한사용경험이있고, 1종의동물에서우려할만한독성이적은경우 ...
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