¡¾µ÷¼Á¡¿±±¾©Ê¯ÓÍ»¯¹¤Ñ§Ôº2024Äê16¸öרҵ½ÓÊܵ÷¼Á
²é¿´: 2565  |  »Ø¸´: 28
¡¾½±Àø¡¿ ±¾Ìû±»ÆÀ¼Û25´Î£¬×÷Õßsunny1225Ôö¼Ó½ð±Ò 20 ¸ö

sunny1225

Ìú¸Ëľ³æ (СÓÐÃûÆø)


[×ÊÔ´] ICH Q11ÎÊ´ðÖÐÓ¢¶ÔÕÕ

ICH ÓÚ2016Äê11Ô¹«²¼ÁËICH Q11µÄÎÊ´ð²Ý°¸£¬Å·ÃË¡¢¼ÓÄôóÆÀÂÛ½ØÖ¹ÈÕÆÚ2017.03.15£»PMDA¡¢FDAÔÝδ¸ø³öÆÀÂÛ½ØÖ¹ÈÕÆÚ¡£


×î½üµÃ¿Õ·­ÒëÁËICH Q11ÎÊ´ð£¬ÉÏ´«¹©ÐèÒªµÄÈ˲鿴£¬·­Òë²»Í×Ö®´¦Ô¸ÒâÓë´óÏÀÃǹµÍ¨½»Á÷¡£
Ïȸø¸öÔ¤ÀÀ£ºICH Q11ÎÊ´ðÖÐÓ¢¶ÔÕÕ
QQ½Øͼ20170110162805.png.thumb.jpg
»Ø¸´´ËÂ¥

» ±¾Ìû¸½¼þ×ÊÔ´Áбí

  • »¶Ó­¼à¶½ºÍ·´À¡£ºÐ¡Ä¾³æ½öÌṩ½»Á÷ƽ̨£¬²»¶Ô¸ÃÄÚÈݸºÔð¡£
    ±¾ÄÚÈÝÓÉÓû§×ÔÖ÷·¢²¼£¬Èç¹ûÆäÄÚÈÝÉæ¼°µ½ÖªÊ¶²úȨÎÊÌ⣬ÆäÔðÈÎÔÚÓÚÓû§±¾ÈË£¬Èç¶Ô°æȨÓÐÒìÒ飬ÇëÁªÏµÓÊÏ䣺libolin3@tal.com
  • ¸½¼þ 1 : ICH_Q11ÎÊ´ð-ÖÐÓ¢¶ÔÕÕ.pdf
  • 2017-01-12 09:57:26, 173.98 K
  • ¸½¼þ 2 : ICH_Q11_Q&A(20161109).pdf
  • 2017-01-12 09:59:31, 302.49 K

» ±¾ÌûÒÑ»ñµÃµÄºì»¨£¨×îÐÂ10¶ä£©

» ²ÂÄãϲ»¶

ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

СÅóÓÑ681

ľ³æ (ÕýʽдÊÖ)


7Â¥2017-01-20 22:12:28
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍƼö

лл~~
10Â¥2017-03-09 17:16:58
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

xingyongzoo

Í­³æ (СÓÐÃûÆø)


¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍƼö

ºÜºÃ,¹ýÀ´Ñ§Ï°ÏÂ
21Â¥2018-01-24 10:45:02
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

½ðÉ«ÕÂÓã

Òø³æ (СÓÐÃûÆø)


¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍƼö

ÐÁ¿à
22Â¥2018-04-11 14:37:28
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

liutaoliu

½ð³æ (ÕýʽдÊÖ)


¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍƼö

Â¥Ö÷ÍþÎ䣬лл·ÖÏí
26Â¥2019-06-21 09:26:02
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
¼òµ¥»Ø¸´
liushuai192Â¥
2017-01-14 11:27   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
sarsy3Â¥
2017-01-19 13:40   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
pingshan4Â¥
2017-01-19 19:49   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
jupingwen5Â¥
2017-01-20 15:30   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2017-01-20 17:05   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
topjie18018Â¥
2017-02-07 11:04   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
liujiashen9Â¥
2017-02-07 14:53   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2017-05-08 15:43   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2017-06-02 09:25   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
nihao-201213Â¥
2017-06-21 17:30   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
yanzr14Â¥
2017-06-23 18:01   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
devil03115Â¥
2017-06-24 08:21   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
wslld16Â¥
2017-07-13 16:16   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
7758_52117Â¥
2017-07-26 15:25   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
xhc010118Â¥
2017-12-29 16:30   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
gliuchem19Â¥
2018-01-01 08:39   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
rhythm2015s20Â¥
2018-01-11 09:38   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
wangwencun23Â¥
2018-09-29 13:45   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
cpu074551324Â¥
2018-10-09 16:29   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
cpu074551325Â¥
2018-10-09 16:30   »Ø¸´  
Ëͺ컨һ¶ä
¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
zhenguo8627Â¥
2019-08-01 15:01   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2019-08-29 10:39   »Ø¸´  
lieju_bj29Â¥
2023-03-22 22:10   »Ø¸´  
ÎåÐǺÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
Ïà¹Ø°æ¿éÌøת ÎÒÒª¶©ÔÄÂ¥Ö÷ sunny1225 µÄÖ÷Ìâ¸üÐÂ
¡î ÎÞÐǼ¶ ¡ï Ò»ÐǼ¶ ¡ï¡ï¡ï ÈýÐǼ¶ ¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶
×î¾ßÈËÆøÈÈÌûÍƼö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[ÂÛÎÄͶ¸å] ´ß¸åºóÃë¾Ü +5 lizhengke06 2024-04-19 6/300 2024-04-19 23:44 by peterrjp
[½Ìʦ֮¼Ò] ¹úÄÚ¿ÆÑл·¾³²îµ¼Ö¹úÄÚ¿ÆÑÐˮƽ²îµÄ¸ùÔ´ +3 zju2000 2024-04-18 3/150 2024-04-19 21:46 by songwz
[»ù½ðÉêÇë] »ù½ðºÍÉúСº¢ +33 Ausy 2024-04-15 35/1750 2024-04-19 16:21 by feng6531
[Óлú½»Á÷] ¸µ¿Ëõ£»ù»¯£¬²úÂÊ´óÓÚ°Ù·ÖÖ®Ò»°Ù£¬Çó½â£¬ºÜ¼± 90+5 hsn991013 2024-04-15 11/550 2024-04-19 14:49 by scdxyouji
[ÂÛÎÄͶ¸å] CCS ChemistryͶ¸åÇóÖú 30+3 wfqtriumph 2024-04-17 4/200 2024-04-19 08:56 by Bletilla
[ÂÛÎÄͶ¸å] ¹ú¼ÒÖصãÑз¢¼Æ»®ÂÛÎÄ¿ÉÒÔ·¢MDPIÀïµÄÆÚ¿¯Âð +4 lin_2018 2024-04-17 4/200 2024-04-19 08:46 by TsolmonZ
[Óлú½»Á÷] ÐÖµÜÃÇ°ïÎÒ¿´¿´ÕâÁ½¸ö½á¹¹ÔõôºÏ³É +5 xl2088131 2024-04-17 5/250 2024-04-19 08:09 by Î÷¹Ï˪»ª
[ÂÛÎÄͶ¸å] Ͷ¸åÇóÖú 5+3 ÎÒÊÇÖÞÖÞ°¡ 2024-04-17 5/250 2024-04-18 17:13 by topedit
[»ù½ðÉêÇë] ¹ú¼Ò×ÊÖú²©Ê¿ºóBCµµ³öУºó×ÊÖúµÄ¸ÅÂʶà´ó£¿ +3 ¿¨¿¨ÂÞÌØŶ 2024-04-16 3/150 2024-04-18 12:58 by wolfgangHugh
[¿¼ÑÐ] 0854¼ÆËã»ú¼¼Êõ316·Öµ÷¼Á£¬ÇóÇóµ¼Ê¦ ÀÌÎÒһϣ¬ÓÐѧ¾ÍÉÏ +6 zhushijie218 2024-04-16 7/350 2024-04-17 23:33 by petro
[ÂÛÎÄͶ¸å] ¿ÉÒÔ´òµç»°Îʱ༭²¿ÊÇ·ñ¿ÉÒÔÏÈ·¢Â¼ÓÃ֪ͨÂð +7 Ë«±¶ºÃÔ˽õÀð 2024-04-14 10/500 2024-04-17 13:38 by cjzhu
[»ù½ðÉêÇë] ³Ù¹ú̩ͨ¹ýÏòѧÉú·¢·ÅÀÍÎñ·ÑÔÙ»ØÊյķ½Ê½Ì×È¡¿Æѧ»ù½ðÖصãÏîÄ¿ +6 babu2015 2024-04-13 7/350 2024-04-16 20:32 by sundiv
[¿¼ÑÐ] Çóµ÷¼Á +4 ¹ÃÈÔÂyy 2024-04-15 5/250 2024-04-16 16:16 by chenweiwade
[¿¼ÑÐ] 329Çóµ÷¼Á +6 Kaylawander 2024-04-13 7/350 2024-04-16 12:00 by ·çÀ´»¨¿ª1
[¿¼ÑÐ] Çóµ÷¼Á +4 ÌÒ°¶Ñ© 2024-04-15 5/250 2024-04-15 18:49 by mthwyj
[ÂÛÎÄͶ¸å] with efitor Ô½¾ÃÊDz»ÊÇÔ½ÈÝÒ׾ܸ塣ÎÒµÄÒѾ­Ò»¸ö¶àÔÂÁË +5 lizhengke06 2024-04-14 5/250 2024-04-15 18:33 by jonewore
[¿¼ÑÐ] 334Çóµ÷¼Á +4 ѧҩ¾ÈÈË 2024-04-14 4/200 2024-04-15 15:05 by hunanzang
[²ÄÁÏ×ÛºÏ] ÇëÎÊÄÄÀï¿ÉÒÔ²âÊÔµÍѹÎüÇâµÄPCTÇúÏß +3 yunshengcd 2024-04-14 5/250 2024-04-15 13:59 by zqdsb
[¿¼ÑÐ] 273Çóµ÷¼Á +5 LateÍñ°² 2024-04-15 7/350 2024-04-15 13:01 by LateÍñ°²
[¿¼ÑÐ] 274Çóµ÷¼Á +5 Ëĸö´ó×Ö£¬ÄãµÎº 2024-04-13 6/300 2024-04-15 00:01 by Ëĸö´ó×Ö£¬ÄãµÎº
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û