Bioequivalence and Bioavailability Forum

High CV? [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 23:07 (3706 d 06:44 ago) – Posting: # 16276
Views: 9,323

Dear Helmut,

❝ Adding to Detlew’s wise words: For a CV_wR of 54% I would expect no inflation of the TIE with the FDA’s RSABE and practically none with the EMA’s ABEL.

where did this CV_wR you mention came from? I couldn't detect such a number in this thread. Did you use a crystal ball to figure it out in M.tareq's post? Or do you have some insider information?

Complete thread:

• Sas proc mixed and 4 period partial replicate Cross over M.tareq 2016-05-03 11:35 
  • 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 inflation d_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