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1 前言 1.1 背景采用生物技术得到的药物(生物药物)从1980年代开始开发,第一个上市的药物在80年代后期被批准,有关这类药物的安全性评价不同的管理机构已发表过几项指导原则和考虑要点,回顾这些从管理权力机构可得到的指导原则对新生物药物的开发提供有用的背景。
1 INTRODUCTION 1.1 Background The development of biomedical drugs (biopharmaceuticals) started in the 1980s. The first marketed drug was approved in the late 1980s. Several regulatory bodies that have evaluated the safety of such drugs have published several Guidelines and considerations, reviewing these guiding principles available from the regulatory authorities provides a useful context for the development of new biopharmaceuticals.