Bioequivalence and Bioavailability Forum • Representative batches?

Representative batches? [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2010-08-05 10:58 (5792 d 00:09 ago) – Posting: # 5724
Views: 20,219

Dear ElMaestro, dear Helmut and all who contribute to this fruitful discussion

❝ I changed the category; doesn’t look as a statistical issue to me (any more).

You are right Helmut, I made the same experience, at the beginning it looks like a statistical problem but in the course of discussion it turned out that it becomes more and more a regulatory issue. But can you argue with the assessor without statistics?

As other sponsors we selected T & R batches which matched closely. Comparative dissolution profiles showed similarity and the assay content differed less than 5%.
From the quality point of view we see no difference between the batches.

The logic consequence would be that for the release of any batch you produce for the market you have to perform a BE study as quality control.

I am still at a loss.

Kind regards

Dan

—
Kind regards and have a nice day
Dr_Dan

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