Bioequivalence and Bioavailability Forum • Forget it!

Forget it! [Study Assessment]

posted by Helmut – Vienna, Austria, 2014-12-17 15:49 (4205 d 03:49 ago) – Posting: # 14095
Views: 10,742

Hi cher0424,

❝ Dear Hulmet

Helmut, if you don’t mind.

❝ So if change the batch of Reference, the regulator need sponsor to provide separate and total analysis for each period ?

My example demonstrates how different batches will influence the outcome. That’s exactly why I wrote:

❝ ❝ No regulator would buy that – for good reasons. :stop:

No way. Forget it!

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Complete thread:

BE study with two different batches of the reference product tarak_desai 2014-12-16 06:51
- BE study with two different batches of the reference product cher0424 2014-12-16 07:31
- BE study with two different batches of the reference product ElMaestro 2014-12-16 09:01
  - BE study with two different batches of the reference product cher0424 2014-12-16 09:31
    - Two different batches of R: bad idea Helmut 2014-12-16 13:36
      - Two different batches of R: Analysis separately?? cher0424 2014-12-17 01:49
        
        Two different batches of R: very bad idea Ohlbe 2014-12-17 13:45
        Forget it!Helmut 2014-12-17 14:49
        
        Forget it! cher0424 2014-12-18 01:08
- BE study with two different batches of the reference product jag009 2014-12-16 15:24
  - BE study with two different batches of the reference product felipeberlinski 2014-12-17 20:16

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