extended release [Design Issues]

posted by ioanam – Romania, 2007-01-22 12:35 (6677 d 22:45 ago) – Posting: # 477
Views: 10,810

Dear Sir, I read a protocol for a Be study for an extended - release formulation.
It was a single dose study(only in fasted conditions) and multi- dose study. In this study, the first period of the single dose study was followed by the first period of the steady – state study. The wash out period began after the last dose administered in the steady - state study. The second period was identical with the first one. Is correct this design for the study?
I know that for extended - release formulations must be performed totally different studies (single dose and multi - dose studies) in different periods. Is this correct?
Thank you.

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