随着国内外药品研制与药品监管的经验、教训的日益丰实,人们对药品科学本质的认识逐步深入,药品研究应贯穿于药品整个生命周期已成为共识。药品获批准上市绝不意味研究的结束,因为药品上市前研究的局限性,以及药品上市后仍然存在诸多的未知性。其未知性主要体现在药品有无限的开发 With the experience of drug development and drug supervision at home and abroad, the lesson is increasingly abundant, people’s understanding of the nature of pharmaceutical science and technology gradually deepened, and pharmaceutical research should be implemented through the entire life cycle of pharmaceuticals. The approval of the drug listing will by no means mean the end of the study because of the limitations of the premarket research and the many unknowns that remain after the drug is brought to market. Its unknowns are mainly reflected in the unlimited development of medicines