| ²é¿´: 4761 | »Ø¸´: 80 | ||||||
| ¡¾½±Àø¡¿ ±¾Ìû±»ÆÀ¼Û72´Î£¬×÷Õßzjrzj520Ôö¼Ó½ð±Ò 56.8 ¸ö | ||||||
| µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû | ||||||
[×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£¡£¡£¡£¡£¡£¡ |
» ±¾Ìû¸½¼þ×ÊÔ´Áбí
-
»¶Ó¼à¶½ºÍ·´À¡£ºÐ¡Ä¾³æ½öÌṩ½»Á÷ƽ̨£¬²»¶Ô¸ÃÄÚÈݸºÔð¡£
±¾ÄÚÈÝÓÉÓû§×ÔÖ÷·¢²¼£¬Èç¹ûÆäÄÚÈÝÉæ¼°µ½ÖªÊ¶²úȨÎÊÌ⣬ÆäÔðÈÎÔÚÓÚÓû§±¾ÈË£¬Èç¶Ô°æÈ¨ÓÐÒìÒ飬ÇëÁªÏµÓÊÏ䣺xiaomuchong@tal.com - ¸½¼þ 1 : Analytical_Procedures_and_Methods_Validation_for_Drugs_and_Biologics_Guidance_for_Industry.pdf
2016-01-25 19:16:00, 133.79 K
» ÊÕ¼±¾ÌûµÄÌÔÌûר¼ÍƼö
·ÂÖÆÒ©Ñз¢É걨 | Ò©ÎïÑз¢ÖªÊ¶ | ÓÐÓõÄ×ÊÔ´ | ×ÊÔ´Ìù |
» ±¾ÌûÒÑ»ñµÃµÄºì»¨£¨×îÐÂ10¶ä£©
» ²ÂÄãϲ»¶
ÇóÖúÇóÖú
ÒѾÓÐ0È˻ظ´
ũҵ×ÊÔ´Óë»·¾³¡¢ÖÇ»Ûũҵרҵ±¾¿ÆÉú±ÏÒµÂÛÎÄ¿ÎÌâÑ¡ÌâÇóÖú
ÒѾÓÐ1È˻ظ´
Ò©ÀíѧÂÛÎÄÈóÉ«/·ÒëÔõôÊÕ·Ñ?
ÒѾÓÐ76È˻ظ´
È˹¤ÖÇÄܸ³ÄܾۺÏÎï¼°¸´ºÏ²ÄÁÏÄ£ÐÍÓ¦ÓÃÓëʵ¼ù
ÒѾÓÐ0È˻ظ´
¸÷¹úºÍ¹ú¼Ê×éÖ¯ÏÖÐÐÒ©µä×¢ÉäÓÃË®ÖÊÁ¿±ê×¼
ÒѾÓÐ0È˻ظ´
ÇóÖúÓÃ΢Æ×Êý¾Ý¿â²éѯ
ÒѾÓÐ0È˻ظ´
¼ÆË㻯ѧÓëÈ˹¤ÖÇÄÜÇý¶¯µÄMOFsÐÔÄÜÔ¤²âÓëɸѡ¼¼Êõ
ÒѾÓÐ0È˻ظ´
ÑÐÈýʵÑéÇóÖ¸µ¼
ÒѾÓÐ0È˻ظ´
½ðÊô²ÄÁ϶à³ß¶È¼ÆËãÄ£Äâ¼¼ÊõÓëÓ¦ÓãºÎ¢¹Û»úÀíµ½ºê¹ÛÐÔÄܵɹ¤×÷
ÒѾÓÐ0È˻ظ´
½Î÷¿Æ¼¼Ê¦·¶´óѧ΢ÉúÎïÌìȻҩÎïÀÏʦ½éÉÜ
ÒѾÓÐ23È˻ظ´
¡¾ÕÐÆ¸¡¿Çå±±£¨¼ÃÄÏ£©ÉúÎï¿Æ¼¼ÕÐÆ¸AIÖÆÒ©Ñз¢¼ÆËãÈ˲Å
ÒѾÓÐ4È˻ظ´
» ±¾Ö÷ÌâÏà¹Ø¼ÛÖµÌùÍÆ¼ö£¬¶ÔÄúͬÑùÓаïÖú:
Springer³ö°æ¡¶¿¹Ìå-Ò©ÎïżÁª¼Á£º21ÊÀ¼Í°©Ö¢µÄÌØÐ§Ò©¡·2015ÄêÓ¢ÎÄÔ°æPDFÏÂÔØ
ÒѾÓÐ177È˻ظ´
¡¾¹ú¼ÊҩѶ¡¿2015Äê7ÔÂ6ÈÕ-7ÔÂ10ÈÕ
ÒѾÓÐ21È˻ظ´
¡¾¹ú¼ÊҩѶ¡¿2015Äê6ÔÂ29ÈÕ-7ÔÂ3ÈÕ¹ú¼ÊÒ©Îï×Éѯ
ÒѾÓÐ17È˻ظ´
¡¾¹ú¼ÊҩѶ¡¿2015Äê6ÔÂ22ÈÕ-6ÔÂ26ÈÕ
ÒѾÓÐ29È˻ظ´
¡¾¹ú¼ÊҩѶ¡¿2015Äê6ÔÂ15ÈÕ-6ÔÂ19ÈÕ
ÒѾÓÐ25È˻ظ´
¡¾¹ú¼ÊҩѶ¡¿2015Äê6ÔÂ8ÈÕ-6ÔÂ12ÈÕ
ÒѾÓÐ15È˻ظ´
¹ú¼ÊҩѶ¡¿2015Äê5ÔÂ1ÈÕ-5ÔÂ8ÈÕ¹ú¼ÊÒ©Îï×ÊѶ֪¶àÉÙ£¬´¿¸É»õ£¬²»†ªà£¡
ÒѾÓÐ27È˻ظ´
FDA 2015Äê4ÔÂ28ÈÕ biosimilar ÉúÎï·ÂÖÆÒ©Èý·ÝеÄÖ¸µ¼ÔÔò³ö¯
ÒѾÓÐ21È˻ظ´
2015Äê1ÔÂCFDA·¢·ÅÎĺÅÖª¶àÉÙ¡¢¡¾Öذõ¡¿ÏÌ´ïÊý¾Ý¿âÐÂÄêм¼ÄÜget
ÒѾÓÐ18È˻ظ´
ÉúÎïÑùÆ·¶¨Á¿·½·¨È·Ö¤Ö¸µ¼ÔÔò---È«Ì×
ÒѾÓÐ189È˻ظ´
ҩѶ2013-3-8
ÒѾÓÐ17È˻ظ´
ҩѶ2012-12-24
ÒѾÓÐ5È˻ظ´
ҩѶ2012-12-14
ÒѾÓÐ6È˻ظ´
ҩѶ2012-12-10
ÒѾÓÐ9È˻ظ´
45Â¥2016-02-04 08:48:25
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£¡
lianghb19886Â¥
2016-01-26 08:31
»Ø¸´
ÎåÐÇºÃÆÀ ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
silentsoul7Â¥
2016-01-26 08:40
»Ø¸´
ÎåÐÇºÃÆÀ ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
xxxx198803058Â¥
2016-01-26 08:41
»Ø¸´
ÎåÐÇºÃÆÀ ¶¥Ò»Ï£¬¸Ðл·ÖÏí£¡
fengsea02149Â¥
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£¡














»Ø¸´´ËÂ¥
hxj5339315