Different method in single ANDA [Bioanalytics]

posted by janmacek – Czech Republic, 2015-02-18 10:06 (3749 d 15:22 ago) – Posting: # 14453
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Dear Compliance,

do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used? In this case I would not expect any problems if the analytical methods are both validated according to the respective guidelines.

With kind regards,

Jan

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