一种产品能在市场上稳固地存在,而且该产品的有效期由相当大的数据库加以保证,要想达到这个目的,需要对产品发展的四个渐进阶段开展不同的工作: 1.新的有效成份阶段,即考虑对一个新药物质、一个新化学实体作为一种研制新药申请备案的那一段时间。 2.产品候选阶段,即在新药申请前进行药物剂型研究的一段时间。 3.新产品阶段,包括为了分配所生产的头几个批量的那一段时间,一般在产品首次上市的两年内。 4.成熟产品阶段,产品经过约两年常规 A product can be solidly on the market and the product is warranted by a fairly large database. To do this, four different phases of product development are required: 1. The new active ingredient Phase, which is to consider a new drug substance, a new chemical entity as a new drug application for the record of that period. 2. Product Candidate Phase, which is a period of time before the new drug application is made. 3. The new product phase, including the time it takes to allocate the first few batches produced, is generally within two years of the product’s first launch. 4. Mature product stage, the product after about two years of routine