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´ÓÍ·¿ªÊ¼: ½ð±Ò+5, ¸Ðл²ÎÓë 2012-11-03 08:19:06
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ÇëÎÊÈçºÎÀí½â¡°Ò»¶¨Òª²Î¿¼ÖÊÁ¿±ê×¼»ò½ø¿Ú×¢²á±ê×¼£¬µ«²»ÄÜÃÔÐÅ¡±£¿ For your reference: Ò»¶¨Òª²Î¿¼ÖÊÁ¿±ê×¼»ò½ø¿Ú×¢²á±ê×¼ This is a very helpful in vitro reference for your dissolution testing. If your drug showed the same in vitro dissolution profile by using the same dissolution method, at least you can start to try PK study. Otherwise you need optimize your formulation further. µ«²»ÄÜÃÔÐÅ The most important is your drug human PK data. You need meet BE range. Therefore even your drug showed the same dissolution profile in vitro as brand drug by using ²Î¿¼ÖÊÁ¿±ê×¼»ò½ø¿Ú×¢²á±ê×¼, you may not have the same BE which means your drug also will have possibility to fail. ÇÒ·¢ÏÖÓÃÉ걨ÁÙ´²ÖÊÁ¿±ê×¼²Ý°¸·½·¨£¬¶ÔÕÕÖÆ¼ÁµÄÈܳöÃ÷ÏÔ¿ìÓÚ×ÔÖÆÖÆ¼ÁµÄ¡£ÎÒÏëÎʵÄÊÇ£¬ÊDz»ÊÇ˵Ã÷´¦·½Òª×ö¸ü¸Ä£¿ Most likely you will have different PK profile. If you are working on generic drug, it is better to improve your formulation to get the same dissolution profile as brand. If in this case, for my daily work, I will immediately modify my formulation to save your future time. |
2Â¥2012-11-03 07:48:09
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