Bioequivalence and Bioavailability Forum

Balaam's design [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2009-09-23 14:47 (6110 d 03:09 ago) – Posting: # 4236
Views: 9,010

Dear Raveendranath!

❝ […] Balaam's design […] can we calculate Intra CV for Reference and Intra CV for Test separately?

Yes, because you have repeated administrations in the the first two sequences.

❝ If yes plz tell me the ANOVA design.

You gave the design already yourself.
I would guess that for FDA and EMEA applications you are on slippery ground (they expect 3- or 4-period replicate designs). On the other hand ANVISA states Balaam’s design in their guideline. Don’t ask me about sample size estimations – no idea…

For the evaluation see:

S-C Chow and J-p Liu
Design and Analysis of Bioavailability and Bioequivalence Studies
Marcel Dekker, New York, pp 257-266 (3^rd ed. 2008)

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Balaam's design graveendranath 2009-09-23 09:13 
  • Balaam's designHelmut 2009-09-23 12:47
    • Balaam's design, sample size d_labes 2009-09-24 16:13
      • Balaam's design graveendranath 2009-09-25 12:23
        • Balaam's design, intra-subject variances d_labes 2009-09-29 14:44
          • Balaam's design, intra-subject variances graveendranath 2009-09-30 13:59
      • Balaam's design, sample size Helmut 2009-09-25 15:44
        • Balaam's design, sample size doubled one more time d_labes 2009-09-28 11:58