| 查看: 1047 | 回复: 2 | |||
| 当前只显示满足指定条件的回帖,点击这里查看本话题的所有回帖 | |||
[交流]
IND(新药临床研究),有一段英文说明,不理解啥意思已有1人参与
|
|||
|
Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. 发自小木虫Android客户端 |
» 猜你喜欢
[求助] 流式死活染 & 单细胞门控设置被质疑,如何优化并解释?
已经有1人回复
蛋白稳定性实验与功能实验不一致
已经有11人回复
药物学论文润色/翻译怎么收费?
已经有245人回复
第4年了,马上40了,可能我与国基确实无缘吧。。。
已经有12人回复
2026年申博药学专业
已经有1人回复
lyblyb1212
铁虫 (初入文坛)
- 应助: 0 (幼儿园)
- 金币: 21
- 红花: 2
- 帖子: 10
- 在线: 6.7小时
- 虫号: 1836701
- 注册: 2012-05-27
- 性别: GG
- 专业: 生物技术药物
★
小木虫: 金币+0.5, 给个红包,谢谢回帖
小木虫: 金币+0.5, 给个红包,谢谢回帖
|
原文:Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. 翻译:现行的联邦法律规定,在药品运输或分发到各州前,药品应当经批准允许上市。 由于申办者可能想将研究用药物运送到各州的临床研究者,因此必须寻求豁免该法律要求。 IND就是申办者从技术上获得FDA豁免的手段。 |
» 本帖已获得的红花(最新10朵)
2楼2017-12-28 16:44:32













回复此楼
LCqingbo