Bioequivalence and Bioavailability Forum • BE Report: Recommendations to the structure

BE Report: Recommendations to the structure [GxP / QC / QA]

posted by mittyri – Russia, 2014-01-22 19:44 (4530 d 06:50 ago) – Posting: # 12229
Views: 25,852

Dear Helmut,

❝ I never referred to the bioanalytical method used for PK there.

Could you specify, where do you include method preparation and validation?

In accordance with your consent I would broaden the question:
BE studies are very specific, and typical Report structure (from E3) should be deeply modified. Sometimes keen discussions are conducted in our department about it. Many men, many minds... I cannot find any recommendations to the structure of BE Report. Please advise

—
Kind regards,
Mittyri

Complete thread:

QA Audit Procedure swapnil.kuche 2011-01-20 06:47 [GxP / QC / QA]
- QA Audit Procedure Helmut 2011-01-20 12:05
- QA Audit Procedure ElMaestro 2011-01-20 13:02
  - QA Audit Procedure Helmut 2011-01-20 14:13
    - QA Audit Procedure Ohlbe 2011-01-20 20:26
      - QC # QA Helmut 2011-01-21 04:23
        
        QC # QA swapnil.kuche 2011-01-21 05:32
        QC # QA ElMaestro 2011-01-21 13:39
        
        QC # QA Ohlbe 2011-01-23 15:18
        
        ISO17025 is King ElMaestro 2011-01-25 13:15
        QC # QA joy_fm 2014-01-15 07:55
        
        QC # QA riteshsrmc 2014-01-16 12:55
        
        QC # QA Mahesh M 2014-01-16 13:30
        
        QC # QA ElMaestro 2014-01-16 13:35
        
        QC # QA joy_fm 2014-01-16 14:55
        
        QC # QA Mahesh M 2014-01-17 12:01
        
        QC # QA joy_fm 2014-01-17 13:42
        
        Waste of time Helmut 2014-01-17 14:16
        
        QC # QA joy_fm 2014-01-20 07:38
        
        QC # QA Ohlbe 2014-01-17 15:27
        
        QC According to ICH E3 mittyri 2014-01-20 14:29
        
        QC According to ICH E3 Helmut 2014-01-20 15:20
        
        BE Report: Recommendations to the structuremittyri 2014-01-22 18:44
        
        BE creative! Helmut 2014-01-22 20:53