Bioequivalence and Bioavailability Forum

The FDA’s fourth BE approach! [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-09-22 16:08 (3930 d 19:21 ago) – Posting: # 15447
Views: 19,513

Dear Helmut, dear all,

Interesting. Seems another Mighty Oracle that went into labour and delivered a mouse.

❝ How could one estimate the sample size? Yet another method for the wish-list of PowerTOST?

Your wish is my command!
Should not that hard to modify power.NTIDFDA() to not shrinken the acceptance range. But in the mean time I suffer from names for the functions in PowerTOST.
How should we baptize the new baby? Or better having an additional argument in the already mature power.NTIDFDA()? If yes, how to name this?

Complete thread:

• New D. Guid­ance – Dabigatran jag009 2015-09-21 23:19 
  • New D. Guid­ance – Dabigatran nobody 2015-09-22 11:04
    • The FDA’s fourth BE approach! Helmut 2015-09-22 11:43
      • The FDA’s fourth BE approach! nobody 2015-09-22 13:06
        • The FDA’s fourth BE approach! Helmut 2015-09-22 13:25
          • The FDA’s fourth BE approach! Yada Yada Yada jag009 2015-09-23 20:29
            • Yucky… Helmut 2015-09-23 22:06
      • The FDA’s fourth BE approach!d_labes 2015-09-22 14:08
        • New PowerTOST function(s) Helmut 2015-09-22 14:27
          • New PowerTOST function(s) d_labes 2015-09-22 14:59
            • Pradaxa = HVDP (dabi­ga­tran = HVD?) Helmut 2015-09-22 15:16
              • Pradaxa = HVDP (dabi­ga­tran = HVD?) Shuanghe 2015-09-22 16:53
                • HVNTID's d_labes 2015-09-23 08:34
                  • HVNTID's Shuanghe 2015-09-25 16:14
              • Highly variable NTID d_labes 2015-09-23 08:23
                • What a mess! Helmut 2015-09-23 13:20
                  • Messy numbers - PowerTOST V1.3-01 preview d_labes 2015-09-24 09:18
                  • What a mess! Shuanghe 2015-09-25 16:32
        • OT: power.NTIDFDA() Helmut 2015-09-23 00:10
          • OT: power.NTIDFDA() d_labes 2015-09-23 09:37