±±¾©Ê¯ÓÍ»¯¹¤Ñ§Ôº2026ÄêÑо¿ÉúÕÐÉú½ÓÊÕµ÷¼Á¹«¸æ
²é¿´: 4759  |  »Ø¸´: 80
¡¾½±Àø¡¿ ±¾Ìû±»ÆÀ¼Û72´Î£¬×÷Õßzjrzj520Ôö¼Ó½ð±Ò 56.8 ¸ö
µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû

zjrzj520

гæ (СÓÐÃûÆø)


[×ÊÔ´] FDA-2015Äê-¹ØÓÚ·ÖÎö¹ý³ÌºÍ·½·¨ÑéÖ¤

Guidance for Industry
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2015
Pharmaceutical Quality/CMC
ϲ»¶Ò»µãÒªµãÔÞŶ£¡£¡£¡£¡£¡£¡
»Ø¸´´ËÂ¥

» ±¾Ìû¸½¼þ×ÊÔ´Áбí

» ÊÕ¼±¾ÌûµÄÌÔÌûר¼­ÍƼö

·ÂÖÆÒ©Ñз¢É걨 Ò©ÎïÑз¢ÖªÊ¶ ÓÐÓõÄ×ÊÔ´ ×ÊÔ´Ìù

» ±¾ÌûÒÑ»ñµÃµÄºì»¨£¨×îÐÂ10¶ä£©

» ²ÂÄãϲ»¶

» ±¾Ö÷ÌâÏà¹Ø¼ÛÖµÌùÍÆ¼ö£¬¶ÔÄúͬÑùÓаïÖú:

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

yuanbao8892

гæ (³õÈëÎÄ̳)


¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶,ÓÅÐãÍÆ¼ö

²»´í£¬ºÜºÃµØ²Î¿¼
29Â¥2016-01-28 16:08:16
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
²é¿´È«²¿ 81 ¸ö»Ø´ð
¼òµ¥»Ø¸´
xuanyunc2Â¥
2016-01-25 21:18   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
pingshan3Â¥
2016-01-25 23:42   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
moon-cake5Â¥
2016-01-26 08:13   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2016-01-26 08:31   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
silentsoul7Â¥
2016-01-26 08:40   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2016-01-26 08:41   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
2016-01-26 08:42   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
wang_q_h10Â¥
2016-01-26 08:47   »Ø¸´  
ÈýÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
amunesia11Â¥
2016-01-26 08:59   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
gaoyong58112Â¥
2016-01-26 09:02   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
moonlight_s13Â¥
2016-01-26 10:26   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
lanlanluck14Â¥
2016-01-26 11:00   »Ø¸´  
ÎåÐÇºÃÆÀ  ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
¡î ÎÞÐǼ¶ ¡ï Ò»ÐǼ¶ ¡ï¡ï¡ï ÈýÐǼ¶ ¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[¿¼ÑÐ] 299Çóµ÷¼Á +8 15188958825 2026-03-25 8/400 2026-03-29 01:36 by fmesaito
[¿¼ÑÐ] Ò»Ö¾Ô¸ÖÐÄÏ´óѧ»¯Ñ§0703×Ü·Ö337Çóµ÷¼Á +5 niko- 2026-03-27 5/250 2026-03-28 14:25 by ÌÆãå¶ù
[¿¼ÑÐ] 286Çóµ÷¼Á +4 ¶ªµôÀÁ¶è 2026-03-27 7/350 2026-03-28 08:07 by baoball
[¿¼ÑÐ] ¿¼Ñе÷¼Á +4 Sanmu-124 2026-03-26 4/200 2026-03-27 17:49 by kiokin
[¿¼ÑÐ] 0856µ÷¼Á +5 ÇóÇóÈÃÎÒÓÐÊé¶Á° 2026-03-26 6/300 2026-03-27 15:12 by caszguilin
[¿¼ÑÐ] 279 ·Ö Çóµ÷¼Á +4 ˯¸öºÃ¾õ_16 2026-03-24 4/200 2026-03-27 15:05 by ×íÔÚ·çÀï
[¿¼ÑÐ] 085600£¬²ÄÁÏÓ뻯¹¤321·Ö£¬Çóµ÷¼Á +9 ´ó²öС×Ó 2026-03-27 9/450 2026-03-27 14:30 by mmm just
[¿¼ÑÐ] 081200-11408-276ѧ˶Çóµ÷¼Á +4 ´Þwj 2026-03-26 4/200 2026-03-27 08:04 by chemisry
[¿¼ÑÐ] 351Çóµ÷¼Á +4 Âó¿Ë°¢ÀÚ 2026-03-24 4/200 2026-03-27 00:32 by wxiongid
[¿¼ÑÐ] 289Çóµ÷¼Á +17 ˶ÐǸ° 2026-03-23 17/850 2026-03-26 16:18 by ²»³Ôô~µÄ؈
[¿¼ÑÐ] »úеѧ˶×Ü·Ö317Çóµ÷¼Á£¡£¡£¡£¡ +4 Acaciad 2026-03-25 4/200 2026-03-25 19:59 by hanserlol
[¿¼ÑÐ] ²ÄÁÏÓ뻯¹¤304ÇóBÇøµ÷¼Á +3 Çñgl 2026-03-25 3/150 2026-03-25 19:03 by Ainin_
[¿¼ÑÐ] ÍøÂç¿Õ¼ä°²È«0839Õе÷¼Á +4 w320357296 2026-03-25 6/300 2026-03-25 17:59 by 255671
[¿¼ÑÐ] 302Çóµ÷¼Á +4 ½õÒÂÎÀÌÙ½· 2026-03-25 4/200 2026-03-25 16:29 by ¹¦·ò·è¿ñ
[¿¼ÑÐ] 0854È˹¤ÖÇÄÜ·½ÏòÕÐÊÕµ÷¼Á +4 ÕÂСÓã567 2026-03-24 4/200 2026-03-25 13:29 by 2177681040
[¿¼ÑÐ] 086003ʳƷ¹¤³ÌÇóµ÷¼Á +6 íµíµ111 2026-03-24 6/300 2026-03-25 10:29 by 3Strings
[¿¼ÑÐ] ²ÄÁÏר˶ÕÒµ÷¼Á +5 ¹þ¹þ¹þºðºðºð¹þ 2026-03-23 5/250 2026-03-24 19:07 by ÁËÁËÁËÁË¡£¡£
[¿¼ÑÐ] 344Çóµ÷¼Á +3 desto 2026-03-24 3/150 2026-03-24 10:09 by ²«»÷518
[¿¼²©] 26É격×Ô¼ö +3 whh869393 2026-03-24 3/150 2026-03-24 09:55 by 21018060
[¿¼ÑÐ] 341Çóµ÷¼Á(Ò»Ö¾Ô¸ºþÄÏ´óѧ070300) +5 ·¬ÇÑÍ·--- 2026-03-22 6/300 2026-03-23 23:45 by Txy@872106
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û