FDA: crystal ball [Regulatives / Guidelines]

posted by Averroes – Spain, 2016-05-27 02:01 (3178 d 08:25 ago) – Posting: # 16367
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Hi Helmut and other members,

I would like to rescue this post to know if any member of the forum could share their experiences using truncated AUC0-72 for FDA studies.

We recently performed a study using AUC0-72 (very low CVw indeed) and we would like to know what could we expect from FDA. Any experiences?

Many thanks

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