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[热点] 疑惑? 好孩子好乖 2026-01-17 刚刚
[注册申报] [已完结]药品注册过程中的问题    ( 1 2 ) (11/2391) 美意天 2012-07-20 2012-07-27 09:40:59 by huangq816
[注册申报] [已完结]仿制药要求 (5/670) Lensly 2012-07-24 2012-07-26 15:54:29 by xie86314
[注册申报] [已完结]注册菜鸟求教《药品研制情况申请表》该如何填?已上市中药增加功能主治 (4/1238) bqchen 2012-07-10 2012-07-26 09:26:57 by bqchen
[注册申报] [已完结]关于同品种不同规格注册的问题 (DRDEPI+1)(8/1230) 美意天 2012-07-23 2012-07-25 08:49:15 by yangli1579
[注册申报] [已完结]进口注册,临床试验用药的进口事宜 (4/1261) lixq79 2012-01-12 2012-07-24 14:14:23 by Teresa88
[注册申报] CDE网站改版了,各位大侠如何查药品的申报情况呀    ( 1 2 ) (10/2137) hcx1022 2012-07-19 2012-07-24 11:01:38 by wimm36
[注册申报] 默沙东降眼内压新药获批 (评阅+1) (5/649) tdhy 2012-02-27 2012-07-23 12:08:12 by 爱国者911
[注册申报] 有哪家公司申报过特殊剂型的保健食品?国家对该类产品有没有特殊要求? (1/382) 霍大少 2012-07-23 2012-07-23 10:38:34 by 广州蓝韵
[注册申报] [已完结]药品申报    ( 1 2 ) (11/1030) lld126 2012-07-20 2012-07-21 14:31:38 by wzq_2004608
[注册申报] 有谁做过前列地尔注射液质量研究,含量和杂质研究用的是外标法还是内标法? (4/751) tdhy 2012-04-17 2012-07-21 13:51:02 by tdhy
[注册申报] 药品注册与专利    ( 1 2 ) (12/2840) 薄荷柠檬22 2012-03-09 2012-07-20 05:36:15 by hcx1022
[注册申报] [已完结]2007版药品注册管理办法中化药和中药分类问题 (4/2264) mowhl 2012-03-30 2012-07-19 19:14:27 by bzl2134
[注册申报] 就目前的政策现在保健品注册申报容易吗? (3/728) 风的咏叹 2012-07-19 2012-07-19 14:45:37 by crity328
[注册申报] 中药新药临床前研究药学研究资料要注意什么才能提高通过率 (3/1051) 小小强人 2012-07-19 2012-07-19 10:14:11 by Alina8912
[注册申报] 申报中药新药临床批件到省局时的现场考核要注意什么? (4/1160) 空速星痕 2012-07-18 2012-07-18 14:54:33 by Alina8912
[注册申报] 药品注册前期调研的相关问题 (2/582) zqflove 2012-07-18 2012-07-18 09:21:38 by 木凸LOVO
[注册申报] 关于药品注册资料项目4和资料项目7的问题 (0/269) zqflove 2012-07-17 2012-07-17 17:08:49 by zqflove
[注册申报] 【求助】残留溶剂问题? (8/1704) 小薇6702 2011-02-22 2012-07-17 13:22:39 by 如猫似狗
[注册申报] [已完结]药典会 改通用名的事请教一下 (0/311) mengdragon 2012-07-17 2012-07-17 12:46:25 by mengdragon
[注册申报] [已完结]求助:英加韦林标准,可RMB (4/768) 烟灰-Richard 2012-07-10 2012-07-16 13:00:21 by 烟灰-Richard
[注册申报] 【求助】消旋体EE值测定 方法学? (9/1856) kele9955 2010-05-05 2012-07-13 17:41:05 by yugijiang
[注册申报] [已完结]新药申报生产批件问题 (3/1238) enjoywang 2012-07-12 2012-07-13 09:35:48 by sycaicai
[注册申报] 苹果皮制药只罚630万 仅用半年重获GMP证书    ( 1 2 3 ) (评阅+1) (20/2722) 药道人 2011-12-12 2012-07-13 02:44:04 by abs413
[注册申报] [已完结]大陆生产的药品要取得在港澳台销售需要办理什么手续么?急急急 在线等!!! (0/873) mengdragon 2012-07-12 2012-07-12 16:53:19 by mengdragon
[注册申报] 全球十大制药企业营销违规处罚 (评阅+1) (2/1094) xhj0631 2012-07-11 2012-07-12 10:01:25 by cheryy
[注册申报] [关贴]制药业财富500强排行榜~~~~~~~~~~~~~~~~ (0/485) tdhy 2012-07-12 2012-07-12 07:56:33 by tdhy
[注册申报] [已完结]pull time 是什么意思    ( 1 2 ) (11/2527) ringzhu 2012-07-10 2012-07-11 08:33:01 by syndrug.com
[注册申报] 医药中间体的MSDS大家都怎么找那? (1/1146) banshenggu 2011-07-05 2012-07-11 07:33:27 by 稻田守鹰
[注册申报] [已完结]CTD中关于原料药的粗品的质量标准问题 (6/2235) x9v85 2011-10-25 2012-07-03 12:22:04 by 盐酸奎宁
[注册申报] [已完结]请教申报的高手报临床和报产的区别? (0/3930) mengdragon 2012-07-03 2012-07-03 10:43:03 by mengdragon
[注册申报] 新化药 申报临床 关于标准品 (7/1254) wenf98 2012-06-07 2012-07-02 17:01:02 by sxcgb
[注册申报] 部队单位的资质 (5/960) xulihua0610 2012-06-28 2012-07-01 21:57:26 by yingying1588
[注册申报] [已完结]关于研制药品的委托 (9/2184) zigen 2012-06-25 2012-06-29 09:38:00 by zigen
[注册申报] [已完结]替吉奥胶囊在日本的销量或者售价,为什么过了监测器没人报? (5/1253) 窄窄的快乐 2012-06-15 2012-06-26 15:52:52 by txalex
[注册申报] [已完结]请问3.1类新药,报临床8号资料要按CTD格式写吗?    ( 1 2 ) (13/2672) zhouhl0112 2012-02-05 2012-06-26 12:59:59 by txalex
[注册申报] 新药研发的信息调研    ( 1 2 3 ) (25/3949) 陕蛋 2011-05-02 2012-06-25 18:14:54 by yangjun130
[注册申报] 我国自主研发抗乙肝病毒1类新药    ( 1 2 3 4 ) (评阅+2) (30/3995) tdhy 2012-06-16 2012-06-23 06:12:21 by trywpl
[注册申报] [已完结][关贴]请高手、大家们帮着找一下鲁拉西酮原料及其制:剂的质量标准,谢谢! (7/1513) gwmgyp 2011-10-22 2012-06-18 05:01:07 by gwmgyp
[注册申报] 药物审评科学决策学术研讨 (1/448) tdhy 2012-06-15 2012-06-15 13:51:04 by wobaby
[注册申报] 含量测定、有关物质测定都是平行针进样吗?    ( 1 2 ) (11/4228) tdhy 2012-01-06 2012-06-15 11:11:46 by hhw_123
[注册申报] 冻干粉针怎么计算含量更科学呢 (1/2494) steven9188 2012-06-13 2012-06-14 15:43:38 by kennywong
[注册申报] 2012年大药企将在艰难中前行    ( 1 2 3 4 ) (评阅+1) (36/4097) 药道人 2011-12-19 2012-06-14 14:00:46 by limin2012
[注册申报] [已完结]求助硫酸特布他林的专利到期日,要中国和美国的,最好将方法以传授一下!谢谢! (6/1493) 我的背包 2012-06-01 2012-06-14 11:35:15 by mouse103
[注册申报] [已完结]CTD格式化申报 (3/920) 暖暖的脚丫 2012-06-12 2012-06-13 09:06:10 by lgd268
[注册申报] 药品研发项目的费用预算从哪些方面考虑?    ( 1 2 ) (12/3683) tdhy 2012-06-04 2012-06-11 17:25:05 by 你从哪里来
[注册申报] [已完结]药品注册工作的前途    ( 1 2 ) (11/2438) 无聊啊a 2012-06-05 2012-06-11 14:31:23 by fwj123123
[注册申报] [已完结]SFDA药物研究技术指导原则 (3/494) hu琥珀po 2012-06-08 2012-06-09 09:00:56 by hu琥珀po
[注册申报] [已完结]仿制药中的对比研究 (2/419) 江湖药虫 2012-05-30 2012-06-08 15:23:43 by li_yeqing
[注册申报] SFDA对色谱工作站的认可    ( 1 2 ) (11/1097) dqmcq 2012-05-29 2012-06-03 16:00:31 by xbqewpq
[注册申报] 中国疫苗 迈步方知闯世界之难    ( 1 2 ) (评阅+3) (10/1862) tdhy 2012-03-05 2012-06-03 15:27:19 by hoohau
[注册申报] 【转帖】药品注册实用手册    ( 1 2 3 ) (评阅+3) (24/2637) nyyulin 2010-01-07 2012-06-02 06:14:00 by 290105434
[注册申报] [已完结]3.2类化药注册 (4/1361) 041235 2012-05-31 2012-06-01 23:00:28 by yang5536
[注册申报] [已完结]求问药品标准 (1/272) belladonae 2012-06-01 2012-06-01 17:29:23 by xbqewpq
[注册申报] [已完结]3+6类药申报21号资料选做实验问题 (4/1245) zqy1888 2012-05-29 2012-06-01 12:25:45 by jiaohua
[注册申报] 申报临床和申报生产的资料有何区别? (5/3992) tdhy 2012-04-19 2012-05-31 17:45:05 by BMWF1
[注册申报] 申报FDA的新药的原料药是不是必须要到FDA批准的原料药厂商购买? (1/597) zhongliang 2012-05-31 2012-05-31 11:47:04 by cuku
[注册申报] 【求助】6类仿制药的注册资料怎么写?    ( 1 2 3 ) (23/3662) tongnem 2009-06-26 2012-05-24 08:38:18 by 如果可以_319
[注册申报] [已完结]进口药品稳定性问题 (3/838) liu1983660 2012-05-23 2012-05-23 14:11:36 by dingjinglvde
[注册申报] 1.1类新药临床申报28号资料问题 (10/2075) 无云小叶子 2012-04-25 2012-05-21 14:41:16 by tingting2011
[注册申报] 抑郁症病人数量从哪查 (4/546) piaoran0631 2012-05-18 2012-05-19 23:29:38 by zhychen2008
[注册申报] 1.1类新药申报临床研究 (5/2047) phpcsr 2012-05-09 2012-05-17 16:06:12 by tdhy
[注册申报] [已完结]心血管病、糖尿病人数量 (4/898) piaoran0631 2012-05-16 2012-05-17 09:32:01 by piaoran0631
[注册申报] [已完结]求 药品注册咨询电话号码及时间 (4/1258) oleland8826 2012-05-16 2012-05-16 21:40:36 by zmy19881019
[注册申报] 重庆啤酒的乙肝疫苗II期临床揭盲 疫苗组与安慰剂组无显著性差异    ( 1 2 ) (10/2538) 药道人 2011-12-09 2012-05-16 20:04:36 by 金玲xu
[注册申报] 3号资料撰写问题 (3/655) piaoran0631 2012-05-11 2012-05-14 12:54:44 by lijin79833
[注册申报] 盐酸度洛西汀申报类别很奇怪 (7/1370) lijin79833 2012-05-11 2012-05-11 19:57:43 by lxm1008
[注册申报] [已完结]求助阿仑膦酸钠泡腾片申报类型 (7/1069) 84傻子 2012-05-07 2012-05-10 18:19:47 by gwmgyp
[注册申报] [已完结]药品注册现场核查问题 (9/2506) 忘记却犹豫 2012-01-30 2012-05-10 08:28:34 by zyl_72
[注册申报] [已完结]有关中药五类新药有效部位一点疑惑 (1/529) niu416839 2012-05-09 2012-05-09 13:27:51 by chenxiangfei
[注册申报] [已完结]国内聚乙二醇干扰素药物注册申报、研究进度情况 (3/687) lengxiao83 2012-05-08 2012-05-09 12:12:19 by danbomingyue
[注册申报] [已完结][关贴]复方丹参片的临床应用及质量情况调查与分析 (4/699) piaoran0631 2012-05-07 2012-05-08 13:49:38 by piaoran0631
[注册申报] 乳剂注射剂必须得做哪些质量研究项啊? (3/782) tdhy 2012-04-19 2012-05-07 20:33:41 by tdhy
[注册申报] 杂质研究 (6/883) 牛牛乐乐 2012-05-02 2012-05-04 18:30:16 by gwmgyp
[注册申报] [已完结]注射剂方法学方案 (DRDEPI+1)(8/1091) xdxusha 2012-05-03 2012-05-04 13:23:40 by yp3181321
[注册申报] [已完结]FDA 具体例子的CTD模板(Module1-module 5) (0/2221) liuhuachen123 2012-05-04 2012-05-04 10:27:50 by liuhuachen123
[注册申报] [已完结]化3.1对非主流国家药物的仿制以及申报 (6/1133) candaceyoung 2011-07-13 2012-05-03 12:59:20 by ajieoamei
[注册申报] [已完结]滴定法和薄层色谱检验方法怎么验证? (3/2234) gao819 2011-07-22 2012-05-03 06:43:09 by dlp2000
[注册申报] [已完结]求助国内能做抗生素仿制新药申报材料的单位和学校老师 (5/874) cyq129 2011-07-22 2012-05-03 06:42:39 by dlp2000
[注册申报] 2012年3月FDA批准新药 (评阅+1) (8/2193) tdhy 2012-04-28 2012-05-02 11:39:43 by 古可ぷ
[注册申报] [已完结]求助《氟哌噻吨美利曲辛片》进口质量标准,有虫虫有没? (0/411) walexander 2012-04-28 2012-04-28 16:10:03 by walexander
[注册申报] [已完结]Pre-registration与registration的区别    ( 1 2 ) (10/5301) qinhy 2012-04-26 2012-04-28 10:57:43 by wuzhuo12312
[注册申报] [已完结]Tacrolimus的USP35-NF30增补版1的质量标准 (0/294) smiler025 2012-04-26 2012-04-26 15:11:05 by smiler025
[注册申报] [已完结]制剂企业 使用原料药混粉的相关补充申请 (0/436) someone598 2012-04-25 2012-04-25 09:16:27 by someone598
[注册申报] 报新药临床试验 (2/530) 769284652 2012-04-20 2012-04-24 14:04:25 by jiangdanlipl
[注册申报] [已完结]~~~胶囊壳申报资料中的EEC Nr 和 C.I. Nr 是神马意思??~~~~ (4/931) ringzhu 2012-04-16 2012-04-21 11:32:47 by zqgwin
[注册申报] [已完结]盐酸头孢替安酯 药理毒理 (3/861) crabmonkey 2012-04-17 2012-04-19 13:41:59 by 痴夷子皮
[注册申报] [已完结]三类新药申报与该药进口申请之间的关系?    ( 1 2 ) (11/2181) yuanahen 2012-04-14 2012-04-19 13:12:51 by yuanahen
[注册申报] [已完结]原临床批件代理商变更问题 (2/340) lixq79 2012-01-31 2012-04-18 10:19:31 by lixq79
[注册申报] 只在台湾上市的药品算是在国外上市吗 (3/1015) luckyrolin 2012-04-16 2012-04-17 08:13:10 by luckyrolin
[注册申报] [已完结]国内已有同品种不同剂型的品种上市,我们算几类? (8/1884) lixq79 2012-02-20 2012-04-16 17:31:53 by fwj123123
[注册申报] 药品注册对气相色谱的要求 (4/764) piaoran0631 2012-04-14 2012-04-15 00:46:42 by yiyan3577
资源 [ 查看全部 ] 作者 最后发表
[注册申报] 新药研发项目管理知识体系构建----沈阳药科大学 博士学位论文(2009年5月).pdf (25/3087) lwjxz 2012-05-12 2012-07-18 09:43:43 by virtue8511
[注册申报] 2006-2010年化学药品批准情况分析    ( 1 2 ) (62/1894) zcbin 2011-12-13 2012-07-05 20:21:40 by 8415
[注册申报] 【转帖】关于报批的资料 (16/1514) wedeng 2009-11-19 2012-06-26 13:13:12 by jstzcxd
[注册申报] 药品研究实验记录规范性指南(试行)--天津药监局药品审评中心.pdf (10/5215) lwjxz 2011-07-07 2012-06-26 07:19:56 by 萧素
[注册申报] 【转帖】化学药物结构确证研究的技术要求与案例分析--李润涛北京大学药学院2010.12.24 (11/1505) lwjxz 2011-04-01 2012-06-17 09:05:03 by 200923240134
[注册申报] 【转帖】北京大学中医药现代研究中心关于中药研发的讲义(共九章) (7/812) lwjxz 2011-02-20 2012-06-07 07:16:12 by xiongcj5518
[注册申报] [关贴]药品注册管理办法 局令第28号 (0/424) zyl_72 2012-05-22 2012-05-22 13:30:01 by zyl_72
[注册申报] [关贴]【其他】最新国家公布的药品注册资料模板 (38/6622) lwjxz 2009-10-11 2012-04-30 11:12:40 by yongheju
[注册申报] 【转帖】CDE2010 药品注册申报资料的现状与问题--系列文章 (18/2383) lwjxz 2011-03-06 2012-04-29 06:56:08 by 张鑫1373
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