Bioequivalence and Bioavailability Forum • New Zealand

New Zealand [RSABE / ABEL]

posted by nobody – 2015-01-31 12:25 (3756 d 06:20 ago) – Posting: # 14334
Views: 23,170

Hi again!

I wanted to learn something about the New Zealand approach to HVD mentioned in Wonnemann, 2014 (largely identical to Wonnemann, 2015 I guess, haven't read it completely yet). Unfortunately I could not find something at the NZ reg homepage, except for a brand new BE guideline, which, however, mentions HVD only in the context of some "isotope application or replicate design" (emphasize by me) studies, apparently without providing further details:

http://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/bioequivalence-of-medicines.pdf

However, it apparently allows the use of sequential design "for studies expected to require a large number of subjects" (p. 20/44). But it states that it is "(n)ormally not practical to use more than 40 subjects in a bioavailability study", without any justification for this statement...

This appears pretty close to the design outlined in Wonnemann, 2014 for NZ, but no statistical details are provided in the NZ guideline.

Edit: Subject line changed. [Helmut]

—
Kindest regards, nobody

Complete thread:

EMA oracle Helmut 2015-01-27 16:27 [RSABE / ABEL]
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
  - Response from Alfredo García-Arieta nobody 2015-01-30 14:55
    - Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
      - Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
        
        Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
      - General remarks ElMaestro 2015-02-01 18:43
        
        General remarks nobody 2015-02-01 22:04
        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarks Helmut 2015-02-02 14:06
        
        TIE: questions mittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- New Zealandnobody 2015-01-31 11:25
  - New Zealand Helmut 2015-02-01 16:08
    - New Zealand nobody 2015-02-01 22:08
      - New Zealand Helmut 2015-02-01 23:54
        
        New Zealand nobody 2015-02-02 08:07