Bioequivalence and Bioavailability Forum

New PowerTOST function(s) [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2015-09-22 16:59 (3465 d 07:55 ago) – Posting: # 15449
Views: 17,313

Dear Helmut,

❝ welcome back! How was vacation on the lonesome isle far out on the high seas?

Thanks! It was very recreative. And I could practise what I have to do if I will be a rendeer (German Rentier) next time.
Doing nothing the whole blessed day but "Maulaffen feil halten" (to gawk, to sit on one's hands) .

❝ I would not add other argument(s) to power.NTIDFDA(). AFAIK dabigatran is not a NTID.

That astonishes me. I had interpreted the sentence "Dabigatran demonstrated a steep exposure response relationship for both efficacy and safety." as some sort of NTID.

❝ Let’s ask Ben as well.

Good idea. I will wait for his reaction.

BTW: Do you think this sort of BE evaluation is not an "Eintagsfliege" (nine day wonder, ephemera), specific for dabigatran?

Complete thread:

• New D. Guid­ance – Dabigatran jag009 2015-09-21 23:19 [Regulatives / Guidelines] 
  • 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