Science vs. regulations [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-03-06 14:30  – Posting: # 10161
Views: 5,836

Dear Ratnakar,

EMA’s opinion [sic] that AUCt is a reliable estimate of extent of absorption only if AUCt ≥ 80% of AUC is scientifically questionable if (!) IR formulations are concerned (absorption practically completed at 2–4× tmax). Therefore, we need more information.

Cheers,
Helmut Schütz
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