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    

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？
51/1返回列表
查看: 2163  |  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] 085410人工智能专硕317求调剂（0854都可以） +3 xbxudjdn 2026-03-18 3/150 2026-03-18 22:14 by zhq0425
[考研] 281求调剂（0805） +6 烟汐忆海 2026-03-16 15/750 2026-03-18 21:12 by Gaodh_82
[考研] 材料专硕274一志愿陕西师范大学求调剂 +6 薛云鹏 2026-03-13 6/300 2026-03-18 14:14 by 脱颖而出
[考研] 材料，纺织，生物（0856、0710），化学招生啦 +3 Eember. 2026-03-17 9/450 2026-03-18 10:28 by Eember.
[考研] 085601求调剂 +4 Du.11 2026-03-16 4/200 2026-03-17 17:08 by ruiyingmiao
[考研] 290求调剂 +6 孔志浩 2026-03-12 11/550 2026-03-17 14:41 by 周舟舟77
[考研] 一志愿南京大学，080500材料科学与工程，调剂 +4 Jy? 2026-03-16 4/200 2026-03-17 11:02 by gaoqiong
[考研] 283求调剂 +3 听风就是雨； 2026-03-16 3/150 2026-03-17 07:41 by 热情沙漠
[考研] 11408 一志愿西电，277分求调剂 +3 zhouzhen654 2026-03-16 3/150 2026-03-17 07:03 by laoshidan
[考研] 304求调剂 +4 ahbd 2026-03-14 4/200 2026-03-16 16:48 by 我的船我的海
[考研] 283求调剂 +10 小楼。 2026-03-12 14/700 2026-03-16 16:08 by 13811244083
[考研] 070305求调剂 +3 mlpqaz03 2026-03-14 4/200 2026-03-15 11:04 by peike
[考研] 复试调剂 +3 呼呼？~+123456 2026-03-14 3/150 2026-03-14 16:53 by WTUChen
[考研] 学硕285求调剂 +13 Wisjxn 2026-03-12 46/2300 2026-03-14 10:33 by JourneyLucky
[考研] 304求调剂 +6 Mochaaaa 2026-03-12 7/350 2026-03-13 22:18 by 星空星月
[考研] 材料工程调剂 +9 咪咪空空 2026-03-12 9/450 2026-03-13 22:05 by 星空星月
[考研] 26调剂/材料科学与工程/总分295/求收留 +9 2026调剂侠 2026-03-12 9/450 2026-03-13 20:46 by 18595523086
[考研] 311求调剂 +3 冬十三 2026-03-13 3/150 2026-03-13 20:41 by JourneyLucky
[考研] 工科材料085601 279求调剂 +8 困于星晨 2026-03-12 10/500 2026-03-13 15:42 by ms629
[考研] 289求调剂 +3 李政莹 2026-03-12 3/150 2026-03-13 11:02 by 求调剂zz
信息提示
关闭
请填处理意见
关闭