Bioequivalence and Bioavailability Forum • Representative batches?

Representative batches? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-08-05 14:45 (5011 d 01:12 ago) – Posting: # 5726
Views: 15,510

Dear Dan!

❝ But can you argue with the assessor without statistics?

Statistics – A subject which most statisticians find difficult
but in which nearly all physicians are expert. Stephen Senn

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone. Stephen Senn; Statistical Issues in Drug Development. Wiley, p386, 2004

❝ 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.

Yes, everybody did/does it that way (see also the last paragraph in ElMaestro’s post). Of course that's not representative, but 'best'.

❝ 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.

Yes, but would be applicable to the innovator as well. I would remind the assessor that this idea was already abandoned 15+ years ago and on the consequences.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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