应《网络安全法》要求，自2017年10月1日起，未进行实名认证将不得使用互联网跟帖服务。为保障您的帐号能够正常使用，请尽快对帐号进行手机号验证，感谢您的理解与支持！

24小时热门版块排行榜    

Znn3bq.jpeg
小木虫论坛-学术科研互动平台 » 生物医药区 » 新药研发 » 注册申报 » ICH Q1A(R2)括号内的R2有什么代表含义啊？
北京石油化工学院2026年研究生招生接收调剂公告
51/1返回列表
查看: 2203  |  回复: 4
只看楼主 @他人 存档 新回复提醒 (忽略) 收藏    在APP中查看

lishutuo

禁虫 (初入文坛)
本帖内容被屏蔽

» 猜你喜欢

» 本主题相关价值贴推荐，对您同样有帮助:
1楼 2013-10-12 15:45:13
已阅   关注TA 给TA发消息 送TA红花 TA的回帖

yi_wang

铁杆木虫 (著名写手)

roye
★ ★
小木虫: 金币+0.5, 给个红包，谢谢回帖
zhychen2008: 金币+1, 多谢回帖交流 2013-10-12 17:22:46
R2是版本号吧？
http://www.fda.gov/downloads/reg ... ances/ucm128204.pdf

ATTACHMENT List of Revision 2 Changes

The revisions to this Q1A guidance result from adoption of the ICH guidance Q1F Stability Data
Package for Registration Applications in Climatic Zones III and IV. The following changes
were made.
1. The intermediate storage condition has been changed from 30°C ± 2°C/60% RH ± 5%
RH to 30°C ± 2°C/65% RH ± 5% RH in the following sections:
·  II.A.7.a (2.1.7.1) Drug Substance - Storage Conditions - General case
·  II.B.7.a (2.2.7.1) Drug Product - Storage Conditions - General case
·  II.B.7.c (2.2.7.3) Drug products packaged in semipermeable containers
·  Glossary (3) Intermediate testing
2. 30°C ± 2°C/65% RH ± 5% RH has been added as a suitable alternative long-term storage
condition to 25°C ± 2°C/60% RH ± 5% in the following sections:
·  II.A.7.a (2.1.7.1) Drug Substance - Storage Conditions - General case
·  II.B.7.a (2.2.7.1) Drug Product - Storage Conditions - General case
3. 30°C ± 2°C/35% RH ± 5% RH has been added as a suitable alternative long-term storage
condition to 25°C ± 2°C/40% RH ± 5% and the corresponding example for the ratio of
water-loss rates has been included in the following section:
·  II.B.7.c (2.2.7.3) Drug products packaged in semipermeable containers
Midstream switch of the intermediate storage condition from 30°C ± 2°C/60% RH ± 5% RH to
30°C ± 2°C/65% RH ± 5% RH can be appropriate provided that the respective storage conditions
and the date of the switch are clearly documented and stated in the registration application.
It is recommended that registration applications contain data from complete studies at the
intermediate storage condition 30°C ± 2°C/65% RH ± 5% RH, if applicable, by three years after
the date of publication of this revised guideline in the respective ICH tripartite region
赞一下(1人) 回复此楼
哥泡的不是论坛,是寂寞....
2楼2013-10-12 15:58:03
已阅   关注TA 给TA发消息 送TA红花 TA的回帖

huaxuehu

铜虫 (小有名气)
版本编号
回复此楼
3楼2013-10-13 12:14:05
已阅   关注TA 给TA发消息 送TA红花 TA的回帖

WANTTOKNOW

银虫 (著名写手)
第二修订版，，，，，，，，，
回复此楼
4楼2013-10-14 10:23:16
已阅   关注TA 给TA发消息 送TA红花 TA的回帖

tony.shcn

铁虫 (小有名气)
Revise
回复此楼
5楼2013-10-14 10:40:17
已阅   关注TA 给TA发消息 送TA红花 TA的回帖
相关版块跳转 我要订阅楼主 lishutuo 的主题更新
51/1返回列表
最具人气热帖推荐 [查看全部] 作者 回/看 最后发表
[考研] 生物与医药273求调剂 +15 荔题南墙 2026-04-05 16/800 2026-04-08 12:38 by 1shin_ichi
[考研] 求调剂 +12 张zic 2026-04-05 13/650 2026-04-08 12:37 by 1shin_ichi
[考研] 0703化学 +23 妮妮ninicgb 2026-04-04 26/1300 2026-04-08 12:20 by 白云朵朵飞
[考研] 293调剂 +17 yj1221 2026-04-08 18/900 2026-04-08 11:17 by linachillybaby
[考研] 本科郑州大学，一志愿华东师范大学282求调剂 +21 熊哥xtk 2026-04-07 24/1200 2026-04-08 09:48 by 123考研123
[考研] 计算机408｜在校多次国家级竞赛获奖｜申请调剂 +4 东山大白鹅 2026-04-05 4/200 2026-04-08 00:18 by chongya
[考研] 277、学硕，求调剂 数一104， +11 瓶子PZ 2026-04-07 12/600 2026-04-07 23:30 by 一只好果子?
[考研] 机械调剂 +3 zzzbcb 2026-04-07 3/150 2026-04-07 22:19 by hemengdong
[考研] 266分，一志愿电气工程，本科材料，求材料专业调剂 +9 哇呼哼呼哼 2026-04-02 10/500 2026-04-06 19:47 by jean5056
[考研] 一志愿南航，数一英一学硕317求调剂！！ +6 Acaciad 2026-04-04 6/300 2026-04-06 12:13 by 考研学校招点人
[考研] 一志愿南昌大学，085600，344分求调剂 +9 调剂上岸玘 2026-04-05 10/500 2026-04-06 09:30 by dongzh2009
[考研] 求调剂，一志愿郑州大学材料与化工专硕，英二数二342分，求老师收留 +19 v12abo 2026-04-02 21/1050 2026-04-06 09:29 by 蓝云思雨
[考研] 331求调剂 +8 于征yz 2026-04-05 8/400 2026-04-06 00:54 by fmesaito
[考研] 277求调剂 +4 12A3 2026-04-02 5/250 2026-04-04 20:28 by 蓝云思雨
[考研] 一志愿上海大学生物学346 +3 上海大学346调剂 2026-04-03 3/150 2026-04-04 20:20 by dongzh2009
[考研] 一志愿华北电力大学（北京），材料科学与工程学硕265，求调剂 +11 yelck 2026-04-03 12/600 2026-04-04 19:52 by dongzh2009
[考研] 一志愿东北大学085901土木专硕345求调剂 +3 zxt11111 2026-04-04 3/150 2026-04-04 14:21 by 土木硕士招生
[考研] 274求调剂 +9 顺理成张 2026-04-03 10/500 2026-04-03 15:10 by 啊俊！
[考研] 315求调剂 +6 顺理成张 2026-04-03 8/400 2026-04-03 14:04 by 百灵童888
[考研] 330求调剂 +3 白神呜呼呼 2026-04-02 3/150 2026-04-03 10:15 by 蓝云思雨
信息提示
关闭
请填处理意见
关闭