摘要
初步整理了国家基本药物口服制剂信息,包括药物疾病分类、中英文通用名、剂型、规格、国产批文数量、原研公司、原研商品名、原研剂型、原研规格、BCS分类等,旨在为仿制药一致性评价工作提供借鉴。
To provide references for the therapeutic equivalence evaluation of generic drugs, information on oral preparations in National Essential Drugs List was compiled, including therapeutic category, generic names in both Chinese and English, dosage form, strength, the number of CFDA approval, BCS classification, as well as applicant, proprietary name, dosage form and strength of reference listed drug（RLD）.
出处
《药学进展》
CAS
2016年第3期213-229,共17页
Progress in Pharmaceutical Sciences
关键词
仿制药一致性评价
国家基本药物
口服制剂
参比制剂
生物药剂学分类
therapeutic equivalence evaluation of generic drug
national essential drugs
oral preparation
reference preparation
BCS classification
