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2014Äê2Ô£¬FDA·¢²¼µÄ×îÐÂÖ¸µ¼ÔÔò£ºÒ©Îï·ÖÎö³ÌÐò¼°·½·¨ÑéÖ¤Ö¸µ¼ÔÔò¡£ 20140219 Analytical Procedures and Methods Validation for Drugs and Biologics. ¸ÃÖ¸µ¼ÔÔò½«È¡´ú (1)FDA guidance 20000801 Analytical Procedures and Methods Validation ºÍ (2) FDA guidance 19870201 Submitting Samples and Analytical Data for Methods Validation* (I) Complement ICH guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and validating analytical methods. [ Last edited by lzbsuper on 2014-2-20 at 13:41 ] |
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