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[热点] 萌生出自己或许不适合搞科研的想法,现在跑or等等看? DonYankess 2026-01-16 刚刚
[注册申报] [已完结]两次中试未知杂质谱不一致    ( 1 2 ) (18/2175) fox378 2015-07-03 2015-07-08 08:49:36 by fox378
[注册申报] [已完结]如何查上市药物的药理毒理资料? (8/3300) laner1983 2012-06-17 2015-07-07 10:44:07 by 牛牛妞妞
[注册申报] 大肠杆菌种子库遗传稳定性研究方法 (0/1187) lingdangbao 2015-07-06 2015-07-06 15:17:29 by lingdangbao
[注册申报] [已完结]关于拉科酰胺手性纯度100%的问题    ( 1 2 ) (15/2410) yuanahen 2012-08-08 2015-07-06 12:27:48 by lsmzmsn
[注册申报] (复方)聚乙二醇电解质散的原料问题 (1/625) cuiyubin476 2012-07-25 2015-07-05 07:22:35 by 1958067211
[注册申报] [已完结]外用制剂的注册批批量大小 (2/1528) bca47 2015-05-15 2015-07-03 13:08:50 by keaitao007
[注册申报] 请问原料药外观描述 (7/1086) vicxu 2015-07-02 2015-07-03 10:03:15 by lionguy
[注册申报] 【转帖】药品注册相关资料及表格    ( 1 2 ) (评阅+5) (15/2478) duandian123 2009-09-24 2015-07-03 06:22:47 by lzg753
[注册申报] [已完结]罗氟司特撤回 (1/1508) zjd506 2015-07-01 2015-07-02 09:08:38 by iupo54
[注册申报] [已完结]冻干注射剂中辅料由精氨酸变更为精氨酸盐酸盐 (4/1171) 123shaobo 2015-06-30 2015-07-01 14:59:43 by 123shaobo
[注册申报] [已完结]评审中心数据:已有批准文号与在审品种信息的疑问    ( 1 2 ) (13/1969) wolong66 2015-06-28 2015-07-01 10:33:15 by wangbenzhu
[注册申报] [已完结]各位,我想查一个关于退热贴的进口注册标准,在哪里能查到详细信息呢。 (4/986) flying042 2015-01-04 2015-06-30 06:02:40 by xubiao1990
[注册申报] [已完结]请教一个专利药如果还没到期,如果申报药监局会是否会给发批文 (2/1193) wolong66 2015-06-28 2015-06-29 06:33:11 by xxxkeke
[注册申报] 仿制药研究前期准备工作    ( 1 2 ) (13/5252) tdhy 2014-11-04 2015-06-28 14:16:00 by kuromiyayou
[注册申报] [已完结]“复方左炔诺孕酮片”原研厂家是哪家? (0/1369) 070918 2015-06-26 2015-06-26 17:21:15 by 070918
[注册申报] [已完结]中试批产品稳定性研究 (6/1556) tongliwoai 2015-06-24 2015-06-26 17:04:15 by tongliwoai
[注册申报] 2015.4谢沐风—我国仿制药的“症结”何在-深度剖析~~存在差距的根源    ( 1 2 ) (19/2703) lwjxz 2015-04-18 2015-06-18 08:06:07 by liuyaming
[注册申报] [已完结]蛋白质类药物中蛋白质一级序列覆盖率应该在多少以上? (2/1751) 734649809 2015-06-11 2015-06-17 09:53:20 by cc3135526
[注册申报] [已完结]请帮忙查询下他米巴罗汀和艾曲波帕国内申报审评情况,谢谢 (4/873) 寂寞源于空 2015-06-15 2015-06-16 08:34:16 by 寂寞源于空
[注册申报] [已完结]关于原料药杂质问题    ( 1 2 ) (11/2105) 浪子和 2015-06-11 2015-06-12 15:19:08 by 小白去哪儿了
[注册申报] 化药3类气雾剂改变包装规格可否直接申报    ( 1 2 ) (13/1940) renluhua365 2013-08-01 2015-06-12 14:04:13 by yyx2013
[注册申报] [已完结]注册申请表填写问题    ( 1 2 ) (14/1558) 王娜1313 2015-06-09 2015-06-12 10:58:25 by xunan_818
[注册申报] [已完结]药用包装材料注册申报及使用要点(先玩龙制药股份有限公司 王震) (1/379) panchengwe 2015-06-11 2015-06-11 21:06:15 by 李大权
[注册申报] [已完结]新药的杂质要求    ( 1 2 ) (10/1861) 775921993 2015-06-09 2015-06-11 16:43:10 by dcmyt
[注册申报] [已完结]求助注射剂辅料申报资料及模板 (3/532) a11wxl 2015-06-03 2015-06-11 15:23:51 by youxingyi
[注册申报] [已完结]原料药的工艺验证的投料问题?    ( 1 2 ) (11/2700) Xspring23 2014-10-23 2015-06-11 09:01:57 by youxingyi
[注册申报] [已完结]请问国外已经上市FDA认证药品在国内注册按3类申报总共需要多长时间能拿证? (5/4451) dongyan2720 2015-01-06 2015-06-11 06:39:49 by zhaishizhong
[注册申报] [已完结]微丸包衣相关问题求助 (4/863) fox378 2015-06-09 2015-06-10 16:35:23 by wangfmffl
[注册申报] [已完结]如何从药物经济学方面阐述立题目的与依据 (0/219) 7436834 2015-06-10 2015-06-10 13:46:14 by 7436834
[注册申报] [已完结]求欧洲药典橙皮苷的质量标准及检验方法 (6/2151) jfq1985 2011-08-04 2015-06-08 08:54:10 by 小庸一下
[注册申报] [已完结]复方制剂增加国内外未上市规格的补充申请 (7/1061) CZJ1990 2015-06-04 2015-06-08 08:35:17 by xinquan7
[注册申报] 2015.3.28~29CFDA—生物类似药研发与评价专题研讨班会议资料 (4/1038) lwjxz 2015-06-04 2015-06-07 09:55:57 by mifeng66
[注册申报] [已完结]利奈唑胺片申报属于三类新药还是六类呀? (8/1416) 王娜1313 2015-06-04 2015-06-05 14:57:21 by 征路
[注册申报] [已完结]求助:FDA生物制品IND申请的流程 (0/2620) 醉丨舞 2015-06-05 2015-06-05 13:04:10 by 醉丨舞
[注册申报] [已完结]怎么知道药品是几类药    ( 1 2 ) (10/3527) 王娜1313 2015-06-03 2015-06-05 00:26:22 by karl2100
[注册申报] 注射液研究项目申报中是否需要注射用水的检验记录? (0/440) Lensly 2015-06-04 2015-06-04 15:21:47 by Lensly
[注册申报] [已完结]求助文献下载 (0/342) Emma1106 2015-06-04 2015-06-04 09:54:02 by Emma1106
[注册申报] [已完结]FDA API 注册接触材料问题 (2/544) i03140103 2015-06-01 2015-06-02 09:47:31 by i03140103
[注册申报] 【求助】中间体的质量标准制定    ( 1 2 ) (10/2284) zrm 2010-09-04 2015-06-01 11:55:00 by lhg0209asd
[注册申报] 【求助】原料和中间体、成品检验方法不一样,以后申报材料很麻烦吗 (8/1928) caozh2008 2011-03-25 2015-06-01 07:44:55 by benjia
[注册申报] [已完结]6类药16号资料 (5/921) 小丸丸9 2015-01-27 2015-05-28 14:30:00 by xiaomaque000
[注册申报] [已完结]合成几步反应可以申报?两步可以申报吗?    ( 1 2 ) (15/2982) zcbdml 2014-06-11 2015-05-28 12:18:27 by ZN8023
[注册申报] [已完结]关于研发转注册    ( 1 2 3 ) (27/2953) zhangkun8005 2015-03-09 2015-05-28 06:51:57 by 秋叶飘零
[注册申报] [已完结]谁知道山东绿叶公司新申请的1.6类注射用艾塞那肽缓释微球新增加了什么适应症 (2/1338) lyj126 2015-05-25 2015-05-25 17:09:39 by wangfmffl
[注册申报] [已完结]想报仿制药,别人的工艺有专利怎么办?    ( 1 2 ) (18/2416) 齐儿189 2015-05-21 2015-05-25 16:46:43 by 阿武罗
[注册申报] [已完结]已上市注射剂仅增加静脉注射给药途径,是否按照补充申请4申报?    ( 1 2 ) (17/1617) kely 2015-05-18 2015-05-25 08:39:32 by kely
[注册申报] [已完结]请教中药药材新药申报的起草说明需要具备哪些项目?????? (1/415) skysimon 2015-05-22 2015-05-25 08:30:13 by wimm36
[注册申报] [已完结]求助注射用泼尼松龙琥珀酸钠上市时间及专利情况 (2/960) 705821815 2015-05-19 2015-05-23 22:46:58 by 705821815
[注册申报] [已完结]抢在原研药拿到国内上市批件之前申报的3类药,有什么优势吗?    ( 1 2 3 ) (23/2315) snk405 2015-05-16 2015-05-23 11:24:56 by snk405
[注册申报] [已完结]1类新药药代动力学试验剂量 (6/1243) Tan_zheng 2015-05-14 2015-05-23 10:55:58 by Kingfox2789
[注册申报] 咨询 (22/786) liuxing3982 2015-05-22 2015-05-23 03:56:09 by zhangya
[注册申报] 申报一个3.1类新药必须具备哪些要素,解决哪些问题?    ( 1 2 ) (18/3657) 2008guoym 2013-04-11 2015-05-21 13:23:11 by tingzai0116
[注册申报] [已完结]上市药物的毒理试验 (2/772) shining_nana 2015-05-20 2015-05-21 11:53:25 by judy19851023
[注册申报] [已完结]关于创新新药注册的适用症申报 (8/998) Tan_zheng 2015-05-14 2015-05-21 07:40:06 by Tan_zheng
[注册申报] 中药5类申报资料有谁做过 (1/554) zjwtcm 2015-05-20 2015-05-20 22:16:39 by 核桃芝麻
[注册申报] 1.1、1.2类新药采用特殊审批管理的临床注册相关 (11/1994) Tan_zheng 2015-05-14 2015-05-20 12:22:29 by mooningworld
[注册申报] [已完结]生物制品的生物药剂学的资料从哪里查? (1/534) 钟司悦 2015-05-18 2015-05-19 09:24:25 by mghjkg02
[注册申报] [已完结]关于CDE电子提交的问题,求解答 (6/1934) 彩虹爱好者2 2015-03-19 2015-05-19 06:09:35 by kdl0721
[注册申报] 关于右旋雷贝拉唑钠    ( 1 2 3 ) (21/2165) sq1989 2015-01-04 2015-05-18 16:40:04 by marshalfox
[注册申报] [已完结]有关药品再注册问题,求教各位前辈    ( 1 2 ) (11/1761) i-奈奈 2015-01-19 2015-05-18 10:54:35 by shanyhhappy
[注册申报] [已完结]药品再注册中的要求怎么做 (5/1102) xiaogudong 2015-02-02 2015-05-18 10:50:13 by shanyhhappy
[注册申报] 酒精性肝损伤造模用什么方法比较权威 (0/237) wangtianti 2015-05-15 2015-05-15 10:58:49 by wangtianti
[注册申报] [已完结]药品变更及申报生产 (3/496) xingchen5055 2015-05-07 2015-05-14 13:33:46 by youxingyi
[注册申报] [已完结]药品说明书PDF的下载    ( 1 2 ) (12/3818) flying042 2013-11-06 2015-05-13 06:41:48 by tingzai0116
[注册申报] [已完结]处方中的magnesium aluminosilicate翻译应该是硅酸镁铝还是硅酸铝镁呢? (2/1237) lavenderdxy 2015-05-11 2015-05-12 08:42:38 by lavenderdxy
[注册申报] 化药申报3.1类和3.3类的区别 (7/3386) 学员T3cPQu 2015-05-08 2015-05-11 16:55:15 by 小白去哪儿了
[注册申报] [已完结]请教如何查询中国某药企哪些产品通过FDA认证? (2/2291) feelwma 2015-05-09 2015-05-11 08:51:34 by mghjkg02
[注册申报] [已完结]阿齐沙坦是原料药吗? (8/2164) qiangang8281 2014-04-04 2015-05-09 17:12:41 by williamxiang
[注册申报] [已完结]求美国药典19版本 (0/260) bellgun 2015-05-09 2015-05-09 13:17:30 by bellgun
[注册申报] [已完结]想向各位大神请教小试批,中试批,工艺验证批,商业化生产批的一些概念。 (5/6204) huanxichong 2015-05-05 2015-05-07 16:37:01 by youxingyi
[注册申报] 2015-药品的有关物质研究-成都    ( 1 2 3 4 5 ) (48/3129) LAPOZZG 2015-04-01 2015-05-07 13:40:44 by lwj5828
[注册申报] [已完结]阿加曲班在日本作为孤儿药批准情况,及是否做临床试验。 (2/562) 羁绊AT 2015-05-05 2015-05-06 11:42:22 by 羁绊AT
[注册申报] [已完结]FDA认证后药品研发如何做? (0/808) zhaozh_0105 2015-05-05 2015-05-05 13:12:57 by zhaozh_0105
[注册申报] [已完结]变更冻干曲线 (1/731) judy19851023 2015-02-02 2015-05-02 00:04:14 by 苏小小1221
[注册申报] [已完结]仿制药用资料都在哪里查的啊 ,求链接    ( 1 2 ) (10/1977) DNF魔仙姬 2015-03-16 2015-05-01 09:58:51 by yicaikk
[注册申报] [已完结]已在国外上市,国内未上市但在国内已申请专利的药物,能注册几类药物?    ( 1 2 ) (10/3491) 泛泛知交 2015-04-27 2015-04-30 17:19:25 by k8zj
[注册申报] 怎样能查到埃索美拉唑镁肠溶胶囊的一般药理学资料? (0/274) bhy5012 2015-04-30 2015-04-30 12:41:06 by bhy5012
[注册申报] 求各位大神回答 (0/177) fudandej 2015-04-30 2015-04-30 11:08:52 by fudandej
[注册申报] [已完结]A药+B药+C药得出另一种新特效D药,应该怎么申报?    ( 1 2 3 ) (29/2043) 2300215 2015-04-18 2015-04-28 16:09:46 by gongyunqi
[注册申报] [已完结]吉林省药品检验所 含量测定费用是多少 (0/257) agnes1200 2015-04-28 2015-04-28 09:09:06 by agnes1200
[注册申报] [已完结]药品注册申请报盘能否修改 (2/332) wxh5362 2015-04-27 2015-04-28 08:50:06 by hgmg987
[注册申报] 申报生产的验证批及动态批的稳定性问题 (7/2022) sissilucky 2015-04-22 2015-04-25 09:43:53 by 小不点126
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[注册申报] 新一代可逆性PPI类药物申报临床的前3家均已尘埃落定(审评周报第37期) (14/1166) 虫虫3210 2015-05-19 2015-06-24 10:29:37 by 寂寞源于空
[注册申报] 4月获批品种,你需要知道的都在这里了! (44/1575) 虫虫3210 2015-05-28 2015-06-14 00:10:27 by 醉丨舞
[注册申报] 退审案例分析    ( 1 2 ) (60/2050) 令狐冲1990 2011-11-14 2015-06-12 07:45:38 by liuqiang1300
[注册申报] 【转发】(dxy首发)立项的同志看过来,退审的原因猜一猜    ( 1 2 ) (62/1770) zihuadd 2012-11-07 2015-06-12 04:36:55 by 醉丨舞
[注册申报] 【深阅读】GMP凛冬有多冷?注射剂生产企业新GMP获批现状分析 (13/862) 虫虫3210 2015-01-28 2015-06-03 22:29:55 by 醉丨舞
[注册申报] 浙江全省药品注册监管人员和企业药品注册专员培训班资料汇编--2010.12 (9/1812) lwjxz 2011-07-18 2015-06-02 11:22:04 by candy2015
[注册申报] 【早上市就真的占优势了吗?】仿制药多家的时代听说要来临了!    ( 1 2 ) (65/2066) 虫虫3210 2015-04-15 2015-06-01 10:15:34 by panchengwe
[注册申报] 【转帖】浅析《药品注册现场核查管理规定》PDF.(新增免金币下载) (49/2893) lwjxz 2009-05-10 2015-05-22 05:35:15 by wilsonxyw
[注册申报] 规格变更的研究思路-国家审评中心学习班【已搜索无重复】 (22/1259) taoyuanjing 2012-01-13 2015-05-20 12:53:23 by hu_man
[注册申报] 化药再注册方案 (1/370) xiaogudong 2015-02-03 2015-05-18 10:45:28 by shanyhhappy
[注册申报] 2013年我国化药申报临床回顾    ( 1 2 ) (71/3039) mengdragon 2014-01-15 2015-05-18 06:24:20 by 齐儿189
[注册申报] 2014.12.11广东省CFDA—药品再注册申报要求及注意事项 (29/1323) lwjxz 2014-12-16 2015-05-08 12:58:13 by wangxiang88
[注册申报] 创新药的相关鼓励政策,约吗??;审评周报33期 (19/834) 虫虫3210 2015-04-21 2015-04-29 13:42:44 by BigHappy
[注册申报] 正大天晴肿瘤辅助用药独家剂型即将获批(审评周报31期) (42/1963) 虫虫3210 2015-04-08 2015-04-29 09:25:10 by liuxxiao
[注册申报] 康力元新复方抗菌药十年马拉松反复中匍匐前进(审评周报22) (2/353) 虫虫3210 2015-01-13 2015-04-29 07:15:27 by liuxxiao
[注册申报] 审评周报27期;015年广东省药品交易中心第一轮交易结果出炉 (2/413) 虫虫3210 2015-02-16 2015-04-29 06:57:01 by liuxxiao
[注册申报] 注册流程.rar (13/805) chb1983chb 2012-07-14 2015-04-24 12:50:39 by 贺堃
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