Znn3bq.jpeg
ÉÇÍ·´óѧº£Ñó¿ÆÑ§½ÓÊܵ÷¼Á
²é¿´: 1836  |  »Ø¸´: 16
¡¾½±Àø¡¿ ±¾Ìû±»ÆÀ¼Û2´Î£¬×÷Õ߹¶ÀÀÏÐàÔö¼Ó½ð±Ò 1.5 ¸ö
µ±Ç°Ö»ÏÔʾÂú×ãÖ¸¶¨Ìõ¼þµÄ»ØÌû£¬µã»÷ÕâÀï²é¿´±¾»°ÌâµÄËùÓлØÌû

¹Â¶ÀÀÏÐà

½ûÑÔ (СÓÐÃûÆø)


[×ÊÔ´] ¡¾×ªÌû¡¿ÉóÆÀÑé֤ɫÆ×·½·¨Ö¸ÄÏ

É«Æ×·½·¨ÑéÖ¤ÉóÆÀÖ¸ÄÏ
   ±¾¼¼ÊõÖ¸ÄϵÄÄ¿µÄÊǸøÉóÆÀÈËÔ±ÉóÆÀÑé֤ɫÆ×·½·¨µÄ£¬ ¸ÃÎļþÌÖÂÛÉ«Æ×·½·¨µÄÒªµãºÍ²»×㣬 ÒÔ±ãCDERµÄÉóÆÀÈËÔ±Äܹ»±£Ö¤·½·¨µÄÁ¼ºÃÐÔÄÜ£¬Ò²Ê¹»¯Ñ§¹¤×÷ÕßÁ˽âΪͨ¹ýÉóÆÀÓ¦¸ø³öµÄ×ã¹»µÄÐÅÏ¢¡£¹ú¼ÊЭµ÷»áÒ飨ICH£©1993Ä궨ÒåµÄ·ÖÎöÊõÓÒÑÔÚÕâÒ»Ö¸ÄÏÖÐÔËÓá£
   É«Æ×·½·¨Í¨³£ÓÃÓÚÔ­ÁÏ¡¢Ò©Îï¡¢Ò©ÎïÖÆ¼ÁºÍÉúÎïÌåÒºÖл¯ºÏÎïµÄ¶¨ÐԺͶ¨Á¿¡£Éæ¼°µÄ³É·Ö°üÀ¨ÊÖÐԵĻò·ÇÊÖÐÔµÄÒ©Îï¡¢¹ý³ÌÔÓÖÊ¡¢²ÐÁôÈÜý¡¢¸½¼Ó¼ÁÈç·À¸¯¼Á¡¢·Ö½â²úÎï¡¢´ÓÈÝÆ÷ºÍÃܱհü×°»òÖÆÔì¹ý³ÌÖдøÈëµÄ¿ÉÌáÈ¡ºÍ¿É¹ýÂ˵ÄÔÓÖÊ¡¢Ö²ÎïÒ©ÖеÄũҩºÍ´úлÎïµÈ¡£
   ÊÔÑé·½·¨µÄÄ¿µÄÊǵõ½¿ÉÐÅÀµµÄºÍ׼ȷµÄÊý¾Ý£¬ÎÞÂÛÊÇÓÃÓÚÑéÊÕ¡¢³ö³§¡¢Îȶ¨ÐÔ»òÒ©ÎﶯÁ¦Ñ§Ñо¿¡£µÃµ½µÄÊý¾ÝÓÃÓÚÒ©Æ·¿ª·¢»òÅú×¼ºóµÄ¶¨ÐԺͶ¨Á¿£¬ÊÔÑé°üÀ¨Ô­ÁϵÄÑéÊÕ¡¢Ò©ÎïºÍÒ©ÎïÖÆ¼ÁµÄ³ö³§¡¢¹ý³Ì¼ìÑé(In- process testing)µÄÖÊÁ¿±£Ö¤ºÍʧЧÆÚµÄ½¨Á¢¡£
·½·¨µÄÑéÖ¤ÊÇÓÉÒ©Æ·µÄ¿ª·¢Õß»òʹÓÃÕßÀ´¼ìÑéÆä·½·¨ÊÇ·ñ´ïµ½Ô¤ÆÚµÄ¿É¿¿ÐÔ¡¢×¼È·¶ÈºÍ¾«ÃܶȵĹý³Ì¡£µÃµ½µÄÊý¾Ý³ÉΪ·½·¨µÄÑéÖ¤×ÊÁϵÄÒ»²¿·Ö½»¸øCDER.¡£
   ·½·¨µÄÑéÖ¤¶ÔÓÚÍê³É»ú¹¹Âú×ãµµ°¸ÒªÇó²»ÊÇÒ»´ÎÐԵģ¬¿ª·¢ÕߺÍʹÓÃÕß¶¼Ó¦ÑéÖ¤Æä·½·¨µÄÄÍÓöȻòÄ;ÃÐÔ£¨ruggedness or robustness.£©£¬ÆäËûµÄ·ÖÎöÕß¡¢ÓÃÆäËüÏ൱µÄÒÇÆ÷£¬ÔÚÆäËüµÄÈÕÆÚ»òµØµã£¬ÔÚÒ©Æ·Éú²úÆÚÏÞ(ÓÐЧÆÚ)È«¹ý³Ì£¬·½·¨¶¼Ó¦Äܹ»ÖØÏÖ¡£Èç¹û²úÉúÊý¾ÝµÄ·½·¨Êǿɿ¿µÄ£¬ÄÇôËùµÃµ½µÄÑéÊÕ¡¢³ö³§¡¢Îȶ¨ÐÔ»òÒ©ÎﶯÁ¦Ñ§µÄÊý¾Ý¾ÍÊÇ¿ÉÐÅÀµµÄ¡£ÑéÖ¤µÄ¹ý³ÌºÍ·½·¨µÄÉè¼ÆÓ¦ÔÚ¿ª·¢¹ý³ÌÖÐÖØÒªµÄÊý¾Ý²úÉú֮ǰ£¬Èç¹û·½·¨¸Ä±äÁË£¬»¹Ó¦¸ÃÔÙÑéÖ¤¡£
    ÕâÒ»Ö¸ÄÏÓÉFDA-CDER»¯Ñ§ÖÆÔì¿ØÖÆÐ­µ÷ίԱ»á(CMCCC)µÄ·ÖÎö·½·¨¼¼ÊõίԱ»áÖÆ×÷¡£ËäÈ»ÕâÒ»Ö¸Äϲ»´´Ôì»ò¸øÓèÈκθöÈËȨÁ¦£¬Ò²²»ÓëFDAºÍÒµ½ç²Ù×÷½áºÏÔÚÒ»Æð£¬µ«È·Êµ±í´ïÁ˱¾»ú¹¹¶ÔÉ«Æ×·½·¨ÑéÖ¤µÄµ±Ç°Ë¼Ïë¡£
    ¸½¼þÏÂÔØµØÖ·£ºhttp://bbs.yaozh.com/attachment. ... U5VcnFXeFFJaw%3D%3D
    ±¾ÎÄÀ´Ô´µØÖ·£ºhttp://bbs.yaozh.com/thread-191-1-1.html
»Ø¸´´ËÂ¥
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

gdxinlan

½û³æ (ÕýʽдÊÖ)

±¾ÌûÄÚÈݱ»ÆÁ±Î

9Â¥2010-10-20 13:12:24
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
²é¿´È«²¿ 17 ¸ö»Ø´ð

¹Â¶ÀÀÏÐà

½ûÑÔ (СÓÐÃûÆø)

±¾ÌûÄÚÈݱ»ÆÁ±Î

2Â¥2010-10-15 16:04:34
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

¹Â¶ÀÀÏÐà

½ûÑÔ (СÓÐÃûÆø)

±¾ÌûÄÚÈݱ»ÆÁ±Î

3Â¥2010-10-18 08:51:24
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû

¹Â¶ÀÀÏÐà

½ûÑÔ (СÓÐÃûÆø)

±¾ÌûÄÚÈݱ»ÆÁ±Î

4Â¥2010-10-18 11:54:06
ÒÑÔÄ   »Ø¸´´ËÂ¥   ¹Ø×¢TA ¸øTA·¢ÏûÏ¢ ËÍTAºì»¨ TAµÄ»ØÌû
¡î ÎÞÐǼ¶ ¡ï Ò»ÐǼ¶ ¡ï¡ï¡ï ÈýÐǼ¶ ¡ï¡ï¡ï¡ï¡ï ÎåÐǼ¶
×î¾ßÈËÆøÈÈÌûÍÆ¼ö [²é¿´È«²¿] ×÷Õß »Ø/¿´ ×îºó·¢±í
[½Ìʦ֮¼Ò] ת³¤Æ¸ÁË +4 ¼òµ¥»¯xn 2026-04-13 4/200 2026-04-14 08:27 by syl200707
[¿¼ÑÐ] ¿¼ÑÐÓ¢Ò»ÊýÒ»338·Ö +9 ³¤½­´óѧ¶«Ð£Çø 2026-04-13 10/500 2026-04-14 00:41 by Íõ¬Bè±
[¿¼ÑÐ] BÇø0809 £¬ÊýÒ»Ó¢Ò»£¬290 Çóµ÷¼Á +3 ãöΫ1111 2026-04-12 4/200 2026-04-13 20:35 by ѧԱJpLReM
[¿¼ÑÐ] 274Çóµ÷¼Á +8 ɽ°¢Âû 2026-04-07 8/400 2026-04-13 20:32 by biomen
[¿¼ÑÐ] ±¾¿ÆÖ£ÖÝ´óѧ£¬Ò»Ö¾Ô¸»ª¶«Ê¦·¶´óѧ282Çóµ÷¼Á +28 Ðܸçxtk 2026-04-07 33/1650 2026-04-13 17:48 by ×Þgv
[¿¼ÑÐ] 290Çóµ÷¼Á +18 ¿Â»´È» 2026-04-12 20/1000 2026-04-13 12:56 by cyh¡ª315
[¿¼ÑÐ] 322Çóµ÷¼Á£¬08¹¤¿Æ +4 ½ñÌìÊǸöСºÅ 2026-04-08 4/200 2026-04-13 00:20 by baobaoye
[¿¼ÑÐ] µçÆø¹¤³Ìר˶320Çóµ÷¼Á +5 СÂé×Ó111 2026-04-10 5/250 2026-04-12 10:47 by zhouyuwinner
[¿¼ÑÐ] µ÷¼Á +6 ÇàµÆ²»¸º 2026-04-09 6/300 2026-04-11 20:35 by dongdian1
[¿¼ÑÐ] µç×ÓÐÅÏ¢279Çóµ÷¼Á£¬ÓÐÊé¶Á¾ÍÐÐ +8 wwwooden 2026-04-08 11/550 2026-04-11 20:22 by cq2548
[¿¼ÑÐ] 085410-273Çóµ÷¼Á +6 X1999 2026-04-10 6/300 2026-04-11 10:32 by Delta2012
[¿¼ÑÐ] ¹¤¿Æ273µ÷¼Á +6 X1999 2026-04-09 7/350 2026-04-11 10:23 by zhq0425
[¿¼ÑÐ] ÖÐҩѧµ÷¼Á ³õÊÔ324 +4 Ñó¸Ê¾Õ¡¢ 2026-04-10 6/300 2026-04-11 09:41 by gong120082
[¿¼ÑÐ] 298Çóµ÷¼Á +9 ¶¤¶£ß˶¬¹Ï 2026-04-07 11/550 2026-04-11 09:35 by zhq0425
[¿¼ÑÐ] ²ÄÁÏÀà284µ÷¼Á +40 Ïë»»ÊÖ»ú²»Ïë½âÊ 2026-04-08 48/2400 2026-04-10 23:28 by 314126402
[¿¼ÑÐ] Çóµ÷¼Á +5 ²»»á·ÉµÄÓã@ 2026-04-10 5/250 2026-04-10 19:07 by chemisry
[¿¼ÑÐ] Ò»Ö¾Ô¸211£¬»¯Ñ§Ñ§Ë¶£¬310·Ö£¬±¾¿ÆÖصãË«·Ç£¬Çóµ÷¼Á +27 ŬÁ¦·Ü¶·112 2026-04-07 30/1500 2026-04-10 15:06 by Kilig0317
[¿¼ÑÐ] 314Çóµ÷¼Á +14 weltZeng 2026-04-09 14/700 2026-04-09 23:14 by wolf97
[¿¼ÑÐ] 349ѧ¿Æ»¯Ñ§045106Çóµ÷¼Á£¬»¯Ñ§Àà¶¼¿ÉÒÔ +8 ±£ºÃ¶®¶® 2026-04-08 8/400 2026-04-09 14:03 by xulei3024
[¿¼ÑÐ] Çóµ÷¼Á +11 wwwwabcde 2026-04-07 11/550 2026-04-07 23:16 by JourneyLucky
ÐÅÏ¢Ìáʾ
ÇëÌî´¦ÀíÒâ¼û