Bioequivalence and Bioavailability Forum

Alpha inflation [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 18:06 (2908 d 16:39 ago) – Posting: # 16273
Views: 7,310

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 ...
Meanwhile see this thread and links therein.

Complete thread:

• Sas proc mixed and 4 period partial replicate Cross over M.tareq 2016-05-03 11:35 [Design Issues] 
  • What is the purpose? Helmut 2016-05-03 12:43
    • What is the purpose? M.tareq 2016-05-03 15:06
    • Alpha inflation ? Ohlbe 2016-05-03 15:48
      • Alpha inflationd_labes 2016-05-03 16:06
      • Not with such a high CV Helmut 2016-05-03 17:49
        • High CV? d_labes 2016-05-03 21:07
          • Acc. to WHO PQTm Helmut 2016-05-03 21:58
            • Sofosbuvir d_labes 2016-05-04 11:50