Bioequivalence and Bioavailability Forum • New PowerTOST function(s)

New PowerTOST function(s) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-09-22 16:27 (3465 d 09:31 ago) – Posting: # 15448
Views: 17,368

Dear Detlew,

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

❝ 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?

❝

❝ Should not that hard to modify power.NTIDFDA() to not shrinken the acceptance range. But in the mean time I suffer from names :cool: 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?

I would not add other argument(s) to power.NTIDFDA(). AFAIK dabigatran is actually pretty highly variable (see here: C_max 59.9%, AUC_∞ 52.9% and the Australian PAR). BTW, if you add arguments you would have to change the default theta0 from 0.975 (to 0.95 or even 0.90?).
Will [image]

confuse users. I would suggest new functions like power.RatioSFDA() and sampleN.RatioSFDA() instead. Let’s ask Ben as well.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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