【摘要】 文中讨论了在确定药物有效期时应考虑的几种因素。建议在某些特殊气候区域进行高温高湿等稳定性试验,增加特定的极端试验考察药物稳定性。更多地采取统计分析的方法,必要时采取缩短有效期的方法充分保证药物质量合格边界,只有这样,才能建立合理的有效期。更多还原

【Abstract】 Several key factors of shelf life establishment for drug products were discussed in this paper.It is proposed to test stability at high temperature and high humidity conditions as well as at extreme conditions for specific climate zones.Statistical analysis is recommended in establishing drug products’ shelf life.If necessary,the method reducing shelf life has to be used in order to guarantee the quality of drug products.更多还原