²é¿´: 2936  |  »Ø¸´: 12

lubenle

ÖÁ×ðľ³æ (Ö°Òµ×÷¼Ò)

[½»Á÷] FDA ·¢²¼ÁËANDA Îȶ¨ÐÔÑо¿ Ö¸ÄÏ ²Ý°¸ ÒÑÓÐ10È˲ÎÓë

FDA ¸Õ·¢²¼ÁËANDA Îȶ¨ÐÔÑо¿ Ö¸ÄÏ ²Ý°¸£¬ ÒªÇóANDA°´ÕÕ£ºICH: Q1A£¬ Q1B£¬ Q1C£¬Q1D, Q1E ½øÐÐÎȶ¨ÐÔÑо¿¼°Êý¾Ý·ÖÎö£¡²¢ÔÚÉ걨ʱÌá½»£º

1. Èý¸öÖÐÊÔÅú»òÁ½ÖÐһСÅúÊý¾Ý
2. 6¸öÔµļÓËÙ¼°³¤ÆÚÊý¾Ý£¬½¨Òé ²ÉÈ¡ICHÖмäÌõ¼þÊý¾ÝÖ§³ÅÓÐЧÆÚ
3. ²ÉÈ¡¶àÅúÔ­ÁÏ
4.²ÉÓÃÄÜ´ú±íÉÌÒµ»¯¹¤Òյİü×°·½Ê½
5.Ìṩȫ°ü×°µÄչʾÅú
6. °´ÕÕQ1D¾ØÕó·½Ê½Ê±ÒªÓÐÈýÅú
7.°´ÕÕQ1E£¬ ¸½¼þAµÄÒªÇó¶ÔÊý¾Ý½øÐÐͳ¼Æ·ÖÎö

http://www.fda.gov/downloads/Dru ... ances/UCM320590.pdf

[ Last edited by lubenle on 2012-9-24 at 22:54 ]
»Ø¸´´ËÂ¥
½±¾ÀÖ
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
»ØÌûÖ§³Ö ( ÏÔʾ֧³Ö¶È×î¸ßµÄǰ 50 Ãû )

lubenle

ÖÁ×ðľ³æ (Ö°Òµ×÷¼Ò)

¾ßÌå¼û¸½¼þ£¡´òËãÏòFDA µÝ½»ANDA/DMFµÄÆóÒµ¿ÉÒÔÔڹ涨ÆÚÏÞÄÚ¶ÔÆä½øÐÐÆÀ¼Û»Ø¸´£¬ Ìá³ö¶Ô×Ô¼ºÆóÒµÓÐÁ¦µÄºÏÀíµÄÂÛÊö£¬²ÎÓëFDA Ö¸µ¼ÐÔÎļþµÄÖÆ¶¨¹ý³Ì¡£
Stability Testing of Drug Substances and Products (PDF - 1.2MB).pdf(1.25MB)
http://kuai.xunlei.com/d/GOWFTIXZUTGE?p=130497

[ Last edited by lubenle on 2012-9-25 at 11:44 ]
½±¾ÀÖ
9Â¥2012-09-25 11:39:25
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
ÆÕͨ»ØÌû

guoxz_1982

ľ³æ (ÖøÃûдÊÖ)

»¯Ñ§¹¤×÷Õß

2Â¥2012-09-25 09:35:03
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
лл·ÖÏí£¡
3Â¥2012-09-25 10:24:00
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
лл·ÖÏí£¡
4Â¥2012-09-25 10:36:24
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

jyp2002

Òø³æ (СÓÐÃûÆø)

ËÍÏÊ»¨Ò»¶ä
§Ý§Ý
5Â¥2012-09-25 11:11:15
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
6Â¥2012-09-25 11:13:58
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

dingjinglvde

ľ³æ (ÕýʽдÊÖ)

7Â¥2012-09-25 11:18:30
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

gongyiweimu

ľ³æ (ÖøÃûдÊÖ)

²»¶®£¬¿´¿´
ԶɽƮÃì»ò¿ÉµÇ
8Â¥2012-09-25 11:21:35
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

brighten

ľ³æ (СÓÐÃûÆø)

ËÍÏÊ»¨Ò»¶ä
§Ý§Ý
10Â¥2012-09-25 16:29:52
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
Ïà¹Ø°æ¿éÌø×ª ÎÒÒª¶©ÔÄÂ¥Ö÷ lubenle µÄÖ÷Ìâ¸üÐÂ
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[»ù½ðÉêÇë] ͶƱ:  ÓжàÉÙÈËÊǽñÌì²éϵͳ֪µÀ½á¹ûµÄ£¿ +16 °®¿´ÊéµÄ¿ÉÀÖ 2026-08-26 18/900 2026-08-28 05:13 by winsaint
[»ù½ðÉêÇë] ¹ú×ÔÈ»ÃæÉϸ´ÅÌ~»¶Ó­ÌÖÂÛ (½ð±Ò+5) +11 ÇçÌì¼ÓÓÍ 2026-08-26 12/600 2026-08-28 01:22 by li09465290@
[½Ìʦ֮¼Ò] ÊÛSCIÎÄÕ£¬ÎÒ:8O5.5.1.O.54,¿ÆÄ¿ÆëÈ«,¿É+¼± +3 XLGfUIdOmEAO 2026-08-27 4/200 2026-08-27 22:26 by 3RAFyYXYSwGS
[»ù½ðÉêÇë] ÉêÇëɾ³ý±¾Ìû +6 lyz123lyz 2026-08-27 7/350 2026-08-27 17:31 by Äþ¾²ÖÂÔ¶sy
[»ù½ðÉêÇë] »ù½ðδÖУ¬ÕâÖÖ´ð¸´ÊÇÄ£°åÂ𣿠+5 zhaosm1982 2026-08-27 6/300 2026-08-27 16:00 by lfy8008
[»ù½ðÉêÇë] ¿´°åÉÏÕâô¶àÖеģ¬ÓеãÏñ50ÈËȺÀï49¸öÈ˶¼ÊÇÆ­×ÓµÄÄÇÖָоõ¡­¡­ +5 a089 2026-08-26 6/300 2026-08-27 14:05 by jonewore
[ÎÄѧ·¼²ÝÔ°] ÃÎÏë +3 myrtle 2026-08-26 3/150 2026-08-27 10:01 by angelyueyi
[˶²©¼ÒÔ°] ÊÛSCIÒ»ÇøT0PÎÄÕ£¬ÎÒ:8.O.55.1.O.54,¿ÆÄ¿ÆëÈ«,¿É+¼± +3 LIbGuocjEEYw 2026-08-26 4/200 2026-08-27 02:01 by Ie9AyIAvGbvs
[»ù½ðÉêÇë] 2026ÄêµÄ¹ú¼ÒÉç¿Æ»ù½ðÏîĿͨѶÆÀÉóµÄйæÔòÓëж¯Ïò¡¢ÐÂÌôÕ½ +7 process2012 2026-08-23 10/500 2026-08-26 19:23 by hmhminy
[»ù½ðÉêÇë] Ôõô²é°¡ +5 huang1991js 2026-08-26 5/250 2026-08-26 16:09 by Equinoxhua
[»ù½ðÉêÇë] 2026¹ú×ÔÈ»º¯ÆÀ·Ñµ½ÕË +22 ÑòÑü°å 2026-08-21 25/1250 2026-08-26 15:00 by zuocuiping
[»ù½ðÉêÇë] 2026Äê8ÔÂ25ÈÕ¹ú×ÔÈ»·Å°ñǰͻȻÊÕµ½ÁÐÈëÆÀÉóר¼ÒÓʼþ£¬ÓйØÏµÂ𣿠+25 ľˮ˼¶¹ 2026-08-25 28/1400 2026-08-26 14:53 by draco1987
[»ù½ðÉêÇë] Ϊʲô¹ú×ÔÈ»²»ÄÜÖ±½Ó¹«²¼ +4 bjdxyxy 2026-08-26 4/200 2026-08-26 13:12 by qingmu1201
[»ù½ðÉêÇë] ¹úºÏÀïÃæÄÜ¿´µ½ÁË +7 Ò»»³Ü°Çï 2026-08-26 7/350 2026-08-26 11:23 by zhaosm1982
[»ù½ðÉêÇë] ÏîÄ¿ÐÅÏ¢ºÍ¾­·ÑÐÅÏ¢ÔÚϵͳÀï¶¼¿ÉÒÔ¿´µ½ÁË +6 wittyboy 2026-08-26 14/700 2026-08-26 10:55 by wittyboy
[Ö°³¡ÈËÉú] ѧÉúײ¼û¸¨µ¼Ô±ËÍÍâÂô£¬µÚ¶þÌìÈ«°à¶¼³ÁĬÁË +3 ¾¨ÓãÈÚ½ð_Õã½­_É 2026-08-22 3/150 2026-08-26 09:01 by zzuzxg
[»ù½ðÉêÇë] Å£À´£¡Ã×À´£¡ÃæÀ´£¡ +8 beefly 2026-08-26 8/400 2026-08-26 08:37 by xuzhipiao
[»ù½ðÉêÇë] Ã÷ÌìÓ¦¸Ã¿É²éÁË£¡£¿ +6 chengyan1220 2026-08-23 6/300 2026-08-25 19:45 by zfd97
[½Ìʦ֮¼Ò] Ìø²ÛºóÔÚÑÐÏîÄ¿Ôõô°ì£¿ +5 ¼òµ¥»¯xn 2026-08-22 10/500 2026-08-23 12:38 by ¼òµ¥»¯xn
[»ù½ðÉêÇë] ¿´À´½ñÌì²»»á·Å°ñÁË£¿ +8 chengyan1220 2026-08-21 11/550 2026-08-21 17:52 by dcqxinyang
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û