| 查看: 1308 | 回复: 2 | ||||
organiccooker金虫 (正式写手)
|
[交流]
快来看FDA对化药分类代码的意义，特别是Orphan drug 是什么意义，千万别望文生义哦！已有2人参与
|
|
What do the Chemical Type and Review Classification codes stand for? NDA Chemical Types Number Meaning 1 New molecular entity (NME) 2 New active ingredient 3 New dosage form 4 New combination 5 New formulation or new manufacturer 6 New indication 7 Drug already marketed without an approved NDA 8 OTC (over-the-counter) switch 10 New indication submitted as distinct NDA - not consolidated Review Classifications Letter Meaning P Priority review drug: A drug that appears to represent an advance over available therapy S Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug O Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans 个人感觉信息量虽小，却很有意义！ 给点鼓励哦 |
回复此楼» 收录本帖的淘帖专辑推荐
 药品注册 |
» 猜你喜欢
跪求一支AAV293细胞
已经有1人回复
-
广西医科大学基础医学院自身免疫病课题组招收基础医学、药学和生物学等专业的研究生
已经有7人回复
-
药理学论文润色/翻译怎么收费?
已经有134人回复
-
[学习资料分享] FAERS数据库的不良反应挖掘(频数法/贝叶斯法)
已经有1人回复
-
招收医学、基础医学类调剂研究生
已经有0人回复
-
是否属于脾肾阳虚证
已经有0人回复
-
脑梗怎么治疗
已经有3人回复
-
脑梗怎么治疗
已经有0人回复
-
生物组织中有目标分析物，专属性怎么做
已经有0人回复
lbdtian
至尊木虫 (著名写手)
- 应助: 3 (幼儿园)
- 金币: 14682.6
- 帖子: 2092
- 在线: 465.7小时
- 虫号: 1091650
- 注册: 2010-09-07
- 性别: GG
- 专业: 药物学
2楼2013-08-16 10:57:30
  |
3楼2018-10-26 10:46:54