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[热点] 今年春晚有几个节目很不错,点赞! 瞬息宇宙 2026-02-22 刚刚
[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? (8/1972) 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 (4/780) piaoran0631 2012-04-14 2012-04-15 00:46:42 by yiyan3577
[注册申报] 达摩克利斯之剑 (6/1799) tdhy 2012-04-12 2012-04-14 22:23:42 by adu706650419
[注册申报] [关贴]药品标准讨论 (7/798) wachina 2012-03-07 2012-04-14 10:56:39 by cpuyou
[注册申报] 谁能查到维拉佐酮的标准? (5/1095) caijacky0912 2012-03-08 2012-04-14 10:14:56 by gwmgyp
[注册申报] [已完结]中试研究和稳定性考察可以在集团总部下属的了公司研究吗? (6/1634) 学员i0ugMf 2012-02-15 2012-04-14 08:49:41 by wy7656
[注册申报] 仿制药改规格!    ( 1 2 3 ) (23/3224) tdhy 2012-01-31 2012-04-14 07:11:01 by gwmgyp
[注册申报] [关贴]求教一下,药品注册申报中,要求的外文翻译问题 (12/3949) 181587941 2011-12-03 2012-04-13 05:07:28 by 沉睡的咖啡
[注册申报] [已完结]求助三丁胺的PDE (0/338) williamxiang 2012-04-12 2012-04-12 13:22:05 by williamxiang
[注册申报] [已完结]请问怎么查本已受理品种的受理日期    ( 1 2 ) (14/2005) 526160332 2012-04-09 2012-04-11 13:07:39 by 无双国士
[注册申报] [已完结]新的原料药注册验证方案如何设计 (8/2284) piaoran168 2012-04-01 2012-04-10 09:20:26 by piaoran168
[注册申报] 【转帖】化学药品补充申请审评中发现的几个常见问题 (评阅+2) (金币≥5)(8/273) jrhuang 2009-07-04 2012-04-10 07:22:05 by 兼善道人
[注册申报] [已完结]求助!准确度不同浓度分开做,有影响么? (2/412) leimy123 2012-04-09 2012-04-09 18:14:20 by leimy123
[注册申报] [已完结]求助!!PEG2050的鉴别试验的原理是什么 (2/480) leimy123 2012-04-06 2012-04-09 18:13:51 by leimy123
[注册申报] [已完结]CTD格式里的S.5对照品的要求 (8/2879) xyer1984 2012-03-02 2012-04-09 14:48:25 by wsf.110
[注册申报] 大型药企强强联合的并购,以此在全球确立自己不可动摇的地位 (评阅+1) (2/1058) tdhy 2012-04-05 2012-04-08 10:28:02 by waterma
[注册申报] [已完结]有人熟悉西藏的“藏卫健用字”批文么 (8/1555) wanjiul 2012-04-05 2012-04-07 08:35:57 by wanjiul
[注册申报] [已完结]帮忙看一下TGA与DSC中都说明了哪些内容?刚接触结构确认,谢谢 (1/501) 309122378 2012-04-05 2012-04-05 22:05:45 by leo1359
[注册申报] 制剂专属性试验    ( 1 2 ) (10/1896) 手心biu 2012-03-15 2012-04-05 16:44:56 by zyypku
[注册申报] [已完结]有谁能帮忙查欧洲药典7.1-7.3的USP查询的 (7/1403) caijacky0912 2012-03-01 2012-04-05 11:18:51 by 痴夷子皮
[注册申报] CTD格式    ( 1 2 ) (评阅+2) (18/2040) dugurenlei12 2011-10-21 2012-04-05 08:21:23 by 媛靥
[注册申报] [已完结]USP 35 (7/857) lg11170929 2012-04-02 2012-04-04 20:08:19 by 痴夷子皮
[注册申报] 关节炎药未来市场:生物制剂唱主角 (4/1357) tdhy 2012-03-19 2012-03-31 20:03:54 by 一叶东来
[注册申报] [已完结]一家公司申请进口临床,已批准临床,两年后再次申请该品种的进口临床,怎么回事呢? (5/1764) mowhl 2012-03-29 2012-03-31 15:55:33 by fishlone
[注册申报] [已完结]求助 报临床的现场核查 (4/1049) diliangshi 2012-03-14 2012-03-28 14:37:44 by 晴朗夜空
[注册申报] [已完结]结构确证外吸收光谱(IR) 制图要求 (4/1227) saltwater 2012-03-23 2012-03-26 15:57:39 by saltwater
[注册申报] 【求助】100币求更昔洛韦注射液申报资料 (9/892) linshiyuan 2010-05-26 2012-03-19 07:54:21 by linshiyuan
[注册申报] [已完结]化药(3.1类)已批片剂注射剂临床请教临床试验如何操作? (0/600) cuigang7979 2012-03-17 2012-03-17 15:28:17 by cuigang7979
[注册申报] 关于国内注册的几个疑惑 (4/1239) 左手的魅力 2012-03-14 2012-03-16 09:11:45 by wimm36
[注册申报] 氯吡格雷与阿托伐他汀晶型与制剂 (3/1125) xiaogou123 2011-12-06 2012-03-16 08:23:53 by 笨笨笨笨
[注册申报] [已完结]六类仿制药的过敏实验是否需在GLP实验室进行 (5/1258) taiggll 2012-02-21 2012-03-15 15:06:46 by qinhy
[注册申报] 初审费和国家局审评费多少? (7/1067) tdhy 2012-03-07 2012-03-15 14:06:07 by oleland8826
[注册申报] [已完结]临床前研究的批生产问题 (2/362) yinmin9521 2012-01-31 2012-03-12 14:48:20 by zhang770729
[注册申报] [已完结]药品注册检验完送往CDE后是不是只能等了? (5/1497) xyer1984 2012-03-02 2012-03-12 14:06:00 by wangxiang88
[注册申报] [已完结]求问::俄罗斯联邦药品注册的网站地址    ( 1 2 ) (10/2713) 人参5代 2012-02-06 2012-03-09 12:29:31 by 人参5代
[注册申报] 医药市场仿制药原料规模将全面赶超 (评阅+1) (1/463) tdhy 2012-03-09 2012-03-09 08:10:10 by chenpi886
[注册申报] 亚洲第一新药“外包商”药明康德入驻武汉光谷生物城    ( 1 2 ) (10/2387) tdhy 2012-03-07 2012-03-08 14:38:49 by chemfarm
[注册申报] 【讨论】受理日期与承办日期 (1/2307) luohuan_llt 2011-04-11 2012-03-05 13:56:16 by jlyzhp
[注册申报] [已完结]依折麦布原料药进口(梯瓦印度公司)跟国内哪家公司合作的? (8/2267) xiaogou123 2012-03-02 2012-03-05 10:42:53 by xiaogou123
[注册申报] [已完结]专利未到期时,国内企业是否能进行原料药的生产?    ( 1 2 3 ) (23/4046) ppm_lee 2012-02-13 2012-03-02 09:58:54 by wjy2950
[注册申报] [已完结]求助!哪位有能力的人士能帮忙找到“注射用兰索拉唑冻干粉针”的质量标准啊! (2/711) pharma_李 2012-02-27 2012-02-28 11:58:58 by pharma_李
[注册申报] [已完结]寻 代检软袋包材相容性 (6/1222) lxq0226 2012-02-25 2012-02-28 08:20:02 by lxq0226
[注册申报] [已完结]新药的适应症如何建立啊? (1/691) dengxianqing 2012-02-27 2012-02-27 11:38:11 by 1994yw
[注册申报] [已完结]氯化物含量过高 (DRDEPI+1)(8/1458) qyx_61 2012-02-23 2012-02-24 20:43:51 by lcy198405
[注册申报] FDA批准新药数量(1993-2011) (评阅+2) (5/1466) liyong_029 2012-02-21 2012-02-23 12:03:35 by oleland8826
[注册申报] [已完结]有关破坏试验    ( 1 2 ) (18/2607) linxiao_xi 2012-02-10 2012-02-23 09:15:17 by linxiao_xi
[注册申报] 【求助】最新药品注册技术精讲 第2版 (7/1813) adfxue 2010-02-21 2012-02-23 05:44:43 by lder
[注册申报] [已完结]急求药品注册管理办法附件二---官方版 (4/1662) 碧水寒 2011-12-19 2012-02-21 10:14:52 by p14085639
[注册申报] [已完结][关贴]方法验证出现的Matrix solution的含义 (3/560) dengxianqing 2012-02-11 2012-02-20 14:32:56 by dengxianqing
[注册申报] [已完结]求马丁代尔37版 (7/1384) WANTTOKNOW 2011-12-06 2012-02-18 12:34:35 by WANTTOKNOW
[注册申报] 【求助】马来酸氟吡汀杂质 (9/1442) liyugang 2011-02-25 2012-02-17 17:12:17 by liyugang
[注册申报] [已完结]关于原辅料更换厂家的问题,请大家进来帮个忙 (1/868) demi2516 2012-02-15 2012-02-17 14:30:08 by taoyuanjing
[注册申报] [已完结]我能问个很白痴的问题么,什么是动态核查?    ( 1 2 ) (10/1946) demi2516 2012-02-15 2012-02-17 08:40:39 by 526160332
[注册申报] [已完结]进口药品注册分类及是否临床的疑问 (6/1380) lixq79 2012-02-14 2012-02-15 11:10:09 by yczxc99
[注册申报] 首个立普妥仿制药获通行证 (1/714) mouse103 2012-02-14 2012-02-14 17:08:27 by zghnlpf
[注册申报] [已完结]注册相关知识!! (2/456) hanyun0005 2012-02-08 2012-02-14 09:20:13 by rosehometown
[注册申报] [已完结]一些细节问题 (6/1224) hsdly2007 2012-02-09 2012-02-14 08:25:31 by 526160332
[注册申报] [已完结]查询申报药品情况 (2/401) stonesheng 2012-02-12 2012-02-12 21:28:50 by 神通广大
[注册申报] [已完结]埃索美拉唑的粉针专利号是多少,哪年到期? (2/447) niuxinwen-2004 2012-02-09 2012-02-10 08:22:53 by 痴夷子皮
[注册申报] [已完结]注射用蔗糖 (4/978) targeting 2012-02-06 2012-02-07 09:51:21 by targeting
[注册申报] 标准起草单位品种 (2/342) ririwowo 2012-02-03 2012-02-06 21:03:34 by ririwowo
[注册申报] 合肥立方申报阿格列汀意欲何为?前途如何? (27/3175) williamxiang 2011-11-21 2012-02-05 16:32:15 by 526160332
[注册申报] [已完结]如何申报合成工艺步骤    ( 1 2 ) (12/1898) caijacky0912 2012-02-01 2012-02-03 11:58:31 by caijacky0912
[注册申报] 络活喜标准 (14/1702) chfpl_1 2012-01-30 2012-02-01 09:59:42 by iamzane
[注册申报] [已完结]与药品直接接触的包装材料变更申请 (4/1823) hongweiwei000 2012-01-28 2012-01-30 17:00:40 by hongweiwei000
[注册申报] 中国与日本对于新药注册特殊审批管理的比较 (2/1140) ltxin2009 2012-01-16 2012-01-29 15:12:44 by 小狼851226
[注册申报] [已完结]求USP33版可下载,多谢! (0/233) lizzieyw77 2012-01-28 2012-01-28 23:06:57 by lizzieyw77
[注册申报] 有关物质研究液相梯度洗脱,基线是不是不能走平?    ( 1 2 ) (10/1993) tdhy 2012-01-18 2012-01-20 08:06:52 by ayfyhuwei
[注册申报] 中药真的要沦为保健品了吗 (9/1348) chfpl_1 2011-12-21 2012-01-13 12:37:39 by xiaodou_xl
[注册申报] 最后一天了,2011年生物医药产业重大事件回顾~~~    ( 1 2 3 ) (评阅+2) (20/2780) 药道人 2011-12-31 2012-01-10 17:25:59 by lxt0312
[注册申报] [已完结]新药申报对原料药、辅料有什么要求??? (7/1993) 123小木虫 2011-05-17 2012-01-05 11:16:03 by wangxiang88
[注册申报] [已完结]关于麦芽糖注射液问题 (0/232) hrschentao 2011-12-30 2011-12-30 10:10:57 by hrschentao
[注册申报] [已完结]关于药品过渡期的问题 (0/515) xuyinnan 2011-12-29 2011-12-29 17:30:47 by xuyinnan
[注册申报] 【讨论】关于新药证书和监测期问题~~~    ( 1 2 ) (12/1847) linglsl 2010-11-09 2011-12-29 15:55:34 by wangxiang88
[注册申报] [已完结]求磺胺二甲氧嘧啶及其钠盐质量标准 (0/216) 方方338 2011-12-29 2011-12-29 13:42:35 by 方方338
[注册申报] [已完结]求助吲达帕胺的晶型资料 (1/1007) jiangyuzhu 2011-12-08 2011-12-28 17:16:16 by jiangyuzhu
[注册申报] [已完结]化药3+6如何申报、核查 (1/493) yuhan1980 2011-12-27 2011-12-27 11:29:06 by 玉和
[注册申报] 【讨论】美国IND申报,需要做小试稳定性么? (7/3073) jeffan 2010-07-09 2011-12-27 11:23:58 by News
[注册申报] 【求助】新药注册审批信息查询的相关问题 (8/2007) sxdxland 2011-04-05 2011-12-26 15:41:02 by pharmainfo1
[注册申报] [已完结]3类注射剂报临床要不要提供验证资料 (6/1547) 118zhangyi 2011-12-14 2011-12-26 10:02:22 by hexinhua0920
[注册申报] 氢化蓖麻油的合法来源? (4/496) syhlyq1986 2011-12-22 2011-12-23 07:47:03 by syhlyq1986
[注册申报] [已完结]制剂已取得临床批件,所用原料药报3.1类新药,还需要做临床吗?    ( 1 2 ) (18/2663) 526160332 2011-11-27 2011-12-22 08:52:41 by hexinhua0920
[注册申报] [已完结]做注册,想换工作~求助各位!    ( 1 2 ) (14/1234) hbsjz.lulu 2011-12-15 2011-12-20 16:56:10 by melissa2011
[注册申报] [已完结]CTD格式电子版如何提交?? (1/1134) demi2516 2011-12-19 2011-12-19 19:28:24 by 526160332
[注册申报] 原料进口注册疑问 (0/228) dtpude 2011-12-19 2011-12-19 13:23:54 by dtpude
[注册申报] [已完结]质量标准怎么理解? (7/1307) ltxin2009 2011-12-16 2011-12-17 10:07:13 by 滴水藏海
[注册申报] 印度药典IP2007 Vol-1-3 (评阅+3) (8/1503) windli 2011-12-15 2011-12-16 16:36:08 by fartek
[注册申报] 问注册大牛们,出现什么方面的问题会执行“一票否决” (11/2068) actinide 2011-12-14 2011-12-16 12:22:29 by 可遇不可求
[注册申报] [已完结]求助中药五类新药申报具体要求,最好有模板 (1/5360) 小飞侠SH 2011-12-15 2011-12-15 10:27:37 by hhcc1966
[注册申报] 药品注册申请 (1/415) cherry1124 2011-12-13 2011-12-14 17:05:02 by chxl2011
资源 [ 查看全部 ] 作者 最后发表
[注册申报] [关贴]70个申报资料退审案例分析-内部资料    ( 1 2 3 4 5 6 .. 9 ) (400/13273) sunnybluesea 2012-02-15 2012-03-30 09:35:27 by sunyanrong
[注册申报] 药物研发与讨论研讨班-化学审评案例分析--第十七期—石家庄2011.11.24-25 (29/3143) lwjxz 2011-12-04 2012-03-30 06:56:24 by sunyanrong
[注册申报] 【其他】新药、仿制药的报批 (17/3780) solomoe 2010-11-01 2012-03-22 10:15:19 by zjb-lufia
[注册申报] 【原创】当前我国新药申报技术规范与要求(国家药审中心20101228海口)    ( 1 2 ) (85/6482) cyj1015 2010-12-29 2012-03-18 13:57:50 by 99wxs
[注册申报] 济南CTD培训录音(借花献佛) (24/2086) ltxin2009 2011-06-10 2012-03-07 19:41:18 by w.f.wang
[注册申报] 【转帖】2010.10.15~16北京--药物溶出度检测新技术新方法应用研讨会资料 (6/1006) lwjxz 2011-01-24 2012-03-02 07:13:00 by ljtd1112
[注册申报] [2011] 2Q FDA更新的各类DMF清单 (2/437) crayon 2011-09-22 2012-02-08 15:43:14 by 山河意
[注册申报] 药品注册申请策略浅析--PRA INTERNATIONAL 2011.3.6 (4/854) lwjxz 2011-10-20 2012-01-12 11:56:28 by 诃子
[注册申报] 【转帖】药品审评中心公布《药品技术审评原则和程序》发布日期:20110323 (9/1501) lwjxz 2011-03-24 2012-01-11 13:04:08 by 朝朝于
[注册申报] 临床试验注册程序 (1/627) liyong_029 2012-01-07 2012-01-09 08:31:42 by 小桃1739
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