1) Generic drug
仿制药
1.
Comparative analysis of approved generic drug in China and America;
中美两国批准仿制药情况比较分析
2.
Consideration for the guideline to the generic drugs development and review to meet the revised Drug Registration Regulation;
新版《药品注册管理办法》的实施对仿制药研发与技术评价要求的初步考虑
3.
The current situation of generic drug management in China is analyzed by introducing the regulations of generic drug management of the recent 20 years of US government.
介绍美国政府20多年来针对仿制药管理的主要法规,分析我国仿制药管理的现状。
2) generic drugs
仿制药
1.
generic drugs can no longer simply have to rely on the past and continue to copy the style to imitate to survive.
在全球经济一体化的推动下,在日益统一的知识产权国际保护标准的推行下,仿制药已经不可能再单纯依靠以前的复制式模仿而继续生存下去。
2.
It adopts a simple cost-based pricing method,which takes manufacturing cost and R&D cost in consideration and neglects the difference between generic drugs and innovative drugs.
我国现行的药品定价政策适用于所有的药品,不论是仿制药还是创新药,不论技术创新程度和临床效果,均采用以生产成本和有限研发成本为基础的简单定价方法。
3.
Objective To introduce WHO\'s biowaiver policy for oral generic drugs.
目的介绍WHO关于口服仿制药生物等效豁免的相关政策。
3) generic drug
仿制药品
1.
The formula development and manufacturing processing research in generic drug
指导原则解读系列专题(六) 仿制药品处方与工艺研究
2.
In order to further improve the evaluation system for generic drug and the quality of evaluation, and to enhance the efficiency of drug research and development, this article answered some questions on quality and stability research based on the enacted guidelines.
仿制药品目前在我国研发药品中占有主导地位,为公众健康用药提供了有力的保障;对此类药物的安全有效性和质量可控性做出科学合理的评价,是我国药品评价者需要不断深入思考的课题。
4) biosimilar products
生物仿制药
1.
Discussions on clinical evaluation for biosimilar products
关于生物仿制药临床评价的探讨
5) biological generic drug
生物仿制药物
6) follow-on biologics
仿制生物技术药物
1.
Discussion on preclinical evaluation of follow-on biologics;
对仿制生物技术药物临床前评价的思考
补充资料：仿制
仿造：～品。
说明：补充资料仅用于学习参考，请勿用于其它任何用途。
参考词条