Bioequivalence and Bioavailability Forum

Sample size for RSABE [Power / Sample Size]

posted by d_labes  – Berlin, Germany, 2013-02-01 10:46 (4888 d 21:03 ago) – Posting: # 9940
Views: 13,615

Dear Anu,

there is no simple (or complicated) analytical way to calculate power or estimate the sample size for RSABE due to the complex conditions and requirements for the described methods (FDA or EMA) .

The only way known at moment is via simulations.
Have a look into the paper:
Laszlo Tothfalusi and Laszlo Endrenyi
"Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs"
J Pharm Pharmaceut Sci (www.cspsCanada.org) 15(1) 73 - 84, 2011

Can be accessed online.

See also this thread here in the forum.

Hope this helps.

Complete thread:

• Sample size for RSABE Anu 2013-02-01 07:01 [Power / Sample Size] 
  • Sample size for RSABEd_labes 2013-02-01 09:46
    • Sample size for RSABE Anu 2013-02-07 06:58
      • No analytic solution! Helmut 2013-02-07 12:32
        • Coming soon ... d_labes 2013-02-08 11:57
          • Wow! Helmut 2013-02-08 12:19
            • Wow! Anu 2013-02-09 09:20
              • read… Helmut 2013-02-09 09:35
            • Bigamist d_labes 2013-02-09 18:11
              • Some testing (Part I) Helmut 2013-02-10 18:35
              • Some testing (Part II) Helmut 2013-02-11 01:00
                • Power testing d_labes 2013-02-11 12:03
                  • the unknown x Helmut 2013-02-11 14:40
                • Unequal CVs d_labes 2013-02-15 08:47
                  • Typo Helmut 2013-02-15 13:01