Bioequivalence and Bioavailability Forum • Replicate vs. 2×2×2 (ethics?)

Replicate vs. 2×2×2 (ethics?) [Regulatives / Guidelines]

posted by nobody – 2017-05-08 16:52 (2876 d 00:52 ago) – Posting: # 17317
Views: 23,369

❝ ❝ … and not as a result of outliers

❝

❝ Nobody knows how to deal with this story. :-( Regulations ≠ science. Not required by the FDA…

... sorry, no.

But this "it's safe because it has been shown to be safe in clinical practice over the last decades"-argumentation (question one above) never really went well in EU, I guess. At least you need to write a new, Chapter 2.5-like overview on the pk, pharmacology, safety to make the assessor sleep well next night after reading your application for a generic. On the other hand, assessors for originator's MAs have a much, much better sleep (better sleeping pills?), in my experience...

Edit: Please don’t shout! [Helmut]

—
Kindest regards, nobody

Complete thread:

Highly Variable Drug BE Justification jag009 2017-03-20 04:42 [Regulatives / Guidelines]
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
  - Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
    - Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
      - Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
        
        Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
        
        expected power d_labes 2017-03-21 15:16
        Doesn't hurt! VStus 2017-03-23 14:24
    - Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
    - Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
      - Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
        
        Replicate vs. 2×2×2 (ethics?)nobody 2017-05-08 14:52
        
        Applicability of reference-scaling Helmut 2017-05-10 14:10
        
        Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
        
        Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
        
        Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
        Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
        
        Regulators view of HVD drugs Helmut 2017-05-16 15:01
        What's the problem? ElMaestro 2017-05-17 03:30
        
        What's the problem? nobody 2017-05-17 07:48
        
        What's the problem? nobody 2017-05-17 09:31
        
        What's the problem? DavidManteigas 2017-05-17 11:25
        
        What's the problem? ElMaestro 2017-05-17 12:07
        
        What's the problem? kumarnaidu 2017-07-11 14:43
        
        What's the problem? ElMaestro 2017-07-11 14:56