Bioequivalence and Bioavailability Forum • EMA GL: Batch size in validation

EMA GL: Batch size in validation [Bioanalytics]

posted by Ohlbe – France, 2010-09-08 21:03 (5769 d 09:05 ago) – Posting: # 5898
Views: 6,317

Dear Helmut,

❝ Sure. I meant a full batch (calibrators, QCs) and extracted blanks within.

Oh, I see, sorry I misunderstood what you intended to do. In that case you would of course have the data for the calculation of precision. But the concern regarding sample handling and extraction remains.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

EMA GL: Batch size in validation Helmut 2010-06-10 14:43
- EMA GL: Batch size in validation Helmut 2010-09-07 12:54
- EMA GL: Batch size in validation vajra123 2010-09-08 05:34
  - EMA GL: Batch size in validation Helmut 2010-09-08 12:36
    - EMA GL: Batch size in validation vajra123 2010-09-08 13:19
      - EMA GL: Batch size in validation Helmut 2010-09-08 13:32
        
        EMA GL: Batch size in validation Ohlbe 2010-09-08 18:03
        
        EMA GL: Batch size in validation Helmut 2010-09-08 18:16
        
        EMA GL: Batch size in validationOhlbe 2010-09-08 19:03
        
        EMA GL: Batch size in validation Helmut 2010-09-08 19:07