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1.For future standard repeat-dose GLP animal studies a general limit of 20 mg/kg/day and a maximum concentration of 2%ofMeTHF or CPME would not be expected
to contribute to any toxicity potentially exhibited by an active pharmaceutical ingredient containing these solvents.
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2.The exposures in the animal studies provide human PDE values of 6.2 and 7.4mg/day forMeTHF and CPME respectively based on a 60 kg individual and using extrapolation factors of 5 (rats to humans), 10 (individual variability), and 5 (animal exposure duration).
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1. potentially exhibited by an active pharmaceutical ingredient containing these solvents Õâ°ë¾ä»°ÔÚÄãµÄ·­ÒëÀïûÓÐÌåÏÖ³öÀ´¡£ÄãÊÇÏëŪ¶®ÕâÁ½¾ä»°µÄÒâ˼»¹ÊÇÏë׼ȷ·­Ò룿·­ÒëµÄ»°¿ÉÒÔÕâÑù£ºÔÚ½«À´µÄ±ê×¼ÖØ¸´¸øÒ©GLP¶¯ÎïÊÔÑéÖУ¬ÎÒÃÇ¿ÉÒÔÔ¤¼Æ£¬20 mg/kg/Ìì»òÕß×î¸ß2%ÕâÑùµÄŨ¶È·¶Î§²»»áÓ°Ï캬ÓÐMeTHF»òCPMEÈÜÒºµÄÒ©Îï³É·Ö¿ÉÄܱíÏÖ³öµÄ¶¾ÐÔ¡£     Òâ˼¾ÍÊǺ¬ÓÐÕâÁ½ÖֳɷֵÄÒ©Îï¾ÍËãÓж¾ÐÔ£¬ÔÚÕâ¸öŨ¶È·¶Î§ÀҲûÓÐÕâÁ½ÖֳɷֵÄÊÂ

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13Â¥: Originally posted by hengxing_001 at 2014-05-23 02:39:13
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14Â¥: Originally posted by zsm0507 at 2014-05-23 13:40:58
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