Bioequivalence and Bioavailability Forum • Regarding US FDA guidelines

Regarding US FDA guidelines [Bioanalytics]

posted by sri – 2009-07-09 15:01 (5840 d 18:32 ago) – Posting: # 3945
Views: 6,661

Dear all,
Please clarify me the below sentense which is present in 'Guidance for Industry Bioanalytical Method Validation'.

The calibration (standard) curve should cover the expected unknown sample concentration range in addition to a calibrator sample at lower limit of quantification.

Regards,
Sri

Complete thread:

Regarding US FDA guidelinessri 2009-07-09 13:01 [Bioanalytics]
- Calibration curve issues Helmut 2009-07-09 13:48
  - Calibration curve issues ElMaestro 2009-07-09 18:38
    - Weighing Helmut 2009-07-09 19:24
      - Weighing ElMaestro 2009-07-09 20:06
        
        Weighing Helmut 2009-07-09 21:00
        
        Weighing or weighting ? Ohlbe 2009-07-10 10:33
        
        Weighting! Helmut 2009-07-10 14:07
        
        Weighting! yjlee168 2009-07-16 12:05