Bioequivalence and Bioavailability Forum • inter-batch variability?

inter-batch variability? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-08-04 19:09 (4867 d 08:53 ago) – Posting: # 5716
Views: 15,128

Dear Dan,

interesting question; I am not sure I understand it all, but I am sure there's hope!
First of all, there is no law against variation of any kind.
Second, you do not write anything about but did you receive a deficiency question from module 3 regarding the product's release specifications? After all, this is where the inter-batch variability comes into the picture. If the assessor for module 3 did not comment, then there is no issue.
On the positive side, the assessor tried to use common sense rather than cookbook in his/her assessment. On the negative side, he/she got something wrong in the creative mental process. I strongly recommend you to play the game of regulatory chicken if this is an EU submission.

Feel free to PM me re. this.

—
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