Bioequivalence and Bioavailability Forum • The other way around?

The other way around? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2014-09-11 21:00 (4310 d 12:26 ago) – Posting: # 13485
Views: 6,076

Dear Ohlbe,
Dear Prashant,

I read the question the other way around:
Phenytoin is an entiepileptic which may or may not be an NTID – the jury is still out on that one.
So it is either 90–111 (~high sample size) or 80–125 (~low sample size); when I read it I had the impression that it was a matter of finding out if there is a decent way to get away with the latter.

My own opinion: Get a scientific advice in the RMS you aim for. If they approve 80–125 they are expected to defend their position if the whole thing ends up at CMD(h) or CHMP.

—
Pass or fail!
ElMaestro

Complete thread:

Phenytoin BE Limits prashantmohite 2014-09-11 15:20
- Phenytoin BE Limits Ohlbe 2014-09-11 17:57
  - The other way around?ElMaestro 2014-09-11 19:00
    - Narrowing, widening and typos Ohlbe 2014-09-11 19:25
      - Narrowing, widening and typos prashantmohite 2014-09-12 06:21
        
        Narrowing, widening and typos nobody 2014-09-12 10:30
        
        Narrowing, widening and typos kvgreddy06 2014-09-13 07:18
        
        FDA: phenytoin = NTID? Helmut 2014-09-14 15:24
        
        FDA: phenytoin = NTID? kvgreddy06 2014-09-26 14:17
        
        AUC more critical? Helmut 2014-09-14 15:42
        
        AUC more critical? nobody 2014-09-14 18:31
        
        Narrowing, widening and typos Helmut 2014-09-14 15:39
        
        Narrowing, widening and typos prashantmohite 2014-09-15 07:31