multiple dosage study [Regulatives / Guidelines]

posted by VStus – Poland, 2016-08-25 20:34 (3088 d 20:49 ago) – Posting: # 16576
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Hi, Manesh!

❝ Can we use partial AUC (labeled dose interval) from both fasting and fed two way study instead of AUC(0-tau)?


I can only cite same section of the Guideline once more again... Why not if there is no accumulation and partialAUCs will demonstrate BE. What if these parameters will be highly variable?

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con713246.pdf


Thank you for the reference!

Regards, VStus

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