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本评介考虑到1986年首次上市新药的最重要特性,若有可能就将新药中与其活性十分相似的现有其他药品作一比较。以往上市药物的新适应症和新配方/产品也加以兼顾。 1986午食品药物管理局(FDA)批准了20种新分子实体,其中18种是治疗药和2种诊断用药。这些新药多数是在86年后期被批准,18种治疗药中仅7种于1986上市。除上述新分子实体外,几种新的生物制剂也将在1986年批准和上市。这些产品在治疗药物的发展中标志着生物工程学应用的一个重要突破。
This review takes into account the most important characteristics of new drugs marketed in 1986 and compares, if possible, new drugs with other existing drugs whose activity is very similar. The new indications and new recipes / products of previously marketed drugs have also been taken into consideration. In 1986, the Food and Drug Administration (FDA) approved 20 new molecular entities, of which 18 are therapeutic and 2 diagnostic. Most of these new drugs were approved in late 86, with only 7 of 18 treatments listed in 1986. In addition to the new molecular entities described above, several new biological agents will also be approved and marketed in 1986. These products represent a major breakthrough in bioengineering applications in the development of therapeutic drugs.