Bioequivalence and Bioavailability Forum • No chance against RMS?

No chance against RMS? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-08-10 18:26 (5001 d 04:43 ago) – Posting: # 5765
Views: 15,149

Dear Dan,

Under the first point I think I would add that you have not (have you?) received questions for module 3 and specifications; thus, the potential variability from the studies reflects -at least in part- the natural variation within the specifications that the M3 assessor has accepted.

You are right, a referral will not be triggered if the RMS disagrees. This is a new thing and there is very little you can do. If the RMS enforces a principle that has never been defined in a guideline document and which is not in line with contemporary equivalence thinking then honestly I think this would be a case for the European Generics Association. This is a slow process and not one that can be expected to work here and now.
Having said that, I am pretty sure regulators from BfArM are seeing this thread and giving it some consideration. That would potentially be in your favour.

I actually still believe your product is alive.

—
Pass or fail!
ElMaestro

Complete thread:

inter-batch variability? Dr_Dan 2010-08-04 10:29 [Regulatives / Guidelines]
- inter-batch variability? Pavidus 2010-08-04 11:57
- inter-batch variability? d_labes 2010-08-04 13:58
- inter-batch variability? ElMaestro 2010-08-04 17:09
  - Between study variability common for HVDs Helmut 2010-08-04 19:45
    - Between study variability common for HVDs ElMaestro 2010-08-04 21:01
      - Representative batches? Helmut 2010-08-04 23:42
        
        Representative batches? ElMaestro 2010-08-05 08:40
        
        Representative batches? Helmut 2010-08-05 12:30
        
        Representative batches? Dr_Dan 2010-08-05 08:58
        
        Representative batches? Helmut 2010-08-05 12:45
        
        Confidence intervals vs. point estimators Dr_Dan 2010-08-06 09:55
        
        Confidence intervals vs. point estimators ElMaestro 2010-08-06 12:34
        
        Confidence intervals vs. point estimates Helmut 2010-08-06 13:20
        Confidence intervals vs. point estimators Dr_Dan 2010-08-06 14:44
        
        Confidence intervals vs. point estimators ElMaestro 2010-08-06 15:01
        
        meta analysis? martin 2010-08-06 17:25
        
        meta analysis? ElMaestro 2010-08-06 17:57
        
        meta analysis? Helmut 2010-08-06 18:31
        
        meta analysis? Ohlbe 2010-08-06 23:21
        
        No chance against RMS? Dr_Dan 2010-08-10 12:27
        
        No chance against RMS?ElMaestro 2010-08-10 16:26
  - Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 07:16
    - tlast (Common) Helmut 2016-07-20 10:48
      - tlast (Common) nobody 2019-02-21 15:20
        
        tlast (Common) ElMaestro 2019-02-21 16:32
        
        tlast (Common) nobody 2019-02-21 17:02
        
        tlast (Common) ElMaestro 2019-02-21 18:02
        
        tlast (Common) nobody 2019-02-21 18:17