Bioequivalence and Bioavailability Forum • R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA)

R, packages (e.g. PowerTOST) and regulatory issues (e.g.FDA) [🇷 for BE/BA]

posted by Ohlbe – France, 2013-03-20 11:18 (4415 d 02:04 ago) – Posting: # 10242
Views: 12,240

Dear Jérôme and El Maestro,

❝ For evaluation of BE in R you need e.g. Yung-Jin Lee's excellent BEAR or some codelines of your own making and then the issue becomes more important.

Doesn't the FDA systematically repeat the PK and stats calculations in ANDA BE studies ? If this is indeed the case, there is no reason they should raise any difficulty as long as they manage to reproduce your results.

The discussion may unfortunately be somewhat different in Europe, where repeating the stats is not common practice.

Regards
Ohlbe

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Regards
Ohlbe

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 BfArM Helmut 2013-03-27 14:23