Bioequivalence and Bioavailability Forum • PowerTOST and BfArM

PowerTOST and BfArM [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2013-03-27 15:23 (4840 d 14:56 ago) – Posting: # 10296
Views: 14,157

Hi Jérôme!

❝ […] you have to write a SAP to a local agency, and what are your experience with filing an R based SAP in these cases?

So far I used PowerTOST for the intermediate power analysis and sample size estimation in Two-Stage designs. Protocols were accepted by the German BfARM without any questions; one product approved a while ago.

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

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Complete thread:

R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-19 17:42 [🇷 for BE/BA]
- R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) ElMaestro 2013-03-20 08:11
  - R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Ohlbe 2013-03-20 10:18
    - R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-20 10:32
      - FDA recalculation ElMaestro 2013-03-20 11:41
        
        validation Helmut 2013-03-20 15:06
  - R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) yjlee168 2013-03-20 22:01
    - R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) Jérôme Martin 2013-03-27 11:59
      - PowerTOST and BfArMHelmut 2013-03-27 14:23