The process and time course from drug discovery to approval for marketing can be divided into following process New Chemical Entity(synthesis) Preformulation studies-define the physical and chemical properties Formulation studies-develop the initial features of the proposed pharmaceutical product or dosage form Investigational new drug application (ND)-for initial testing in humans Preclinical and Clinical studies Phase l-initial testing in humans Phase Il, Phase Il -progressive human Trials New drug application(NDA)-seeking approval 吗 gt the new product.The process and time course from drug discovery to approval for marketing can be divided into following process: New Chemical Entity (synthesis) Prefomulation studies-define the physical and chemical properties Formulation studies-develop the initial features of the proposed pharmaceutical product or dosage form Investigational new drug application(IND)-for initial testing in humans Preclinical and Clinical studies Phase I-initial testing in humans Phase II, Phase III -progressive humanTrials New drug application (NDA)-seeking approval to market the new product