Different method in single ANDA [Bioanalytics]

posted by Compliance – India, 2015-02-18 12:16 (3752 d 09:14 ago) – Posting: # 14455
Views: 3,592

❝ do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used?


Yes you are right & also note that both of the method are going to be fully validated as per the guideline.

thanks for sharing your opinion.

Regards,

Compliance

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