Alpha inflation [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 16:06 (2091 d 12:58 ago) – Posting: # 16273
Views: 6,874

(edited by d_labes on 2016-05-03 16:30)

Dear Ohlbe,

» Any idea about alpha inflation control with such a design ?

If the evaluation follows the same line as the EMA recommends for 3- or 4-period studies, namely forget all the data not involved in the respective comparison, the same alpha inflation as for a usual partial replicate design is expected.

See
Munoz et al.
"Consumer’s risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs"
Stat Med. 2016 May 30;35(12):1933-43.
doi: 10.1002/sim.6834. Epub 2015 Dec 28.

The method to control the TIE is coming soon ... :cool:
Meanwhile see this thread and links therein.

Regards,

Detlew

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