Bioequivalence and Bioavailability Forum

inter-batch variability? [Regulatives / Guidelines]

posted by Pavidus – 2010-08-04 11:57 (4344 d 05:05 ago) – Posting: # 5714
Views: 14,472

Dear Dr_Dan & all,

Allow me one general remark:
IMHO BE studies are definitely not suitable to assess inter-batch variability of any product.

I am not saying, that this remark will "save" your product .... discussion with 'assessors' is always difficult...

(btw. nice figures for a highly-variable drug)

Kind regards, P.

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