Pharmaceutical product development R&D –Screening –In vitro characterization –In vivo pharmacology, ADME (Absorption, Distribution, Metabolism, Excretion) –Preliminary toxicology Preclinical –Process chemistry (GMP) –Toxicology (GLP) –Clinical plan –File IND (Investigative New Drug) Clinical –Phase I, Phase II –Phase III –NDA (New Drug Application)
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