Bioequivalence and Bioavailability Forum • IS response?

IS response? [Bioanalytics]

posted by Helmut – Vienna, Austria, 2013-05-02 16:56 (4807 d 12:29 ago) – Posting: # 10526
Views: 5,783

Hi Avinash,

which regulatory agency is your “target”?

For the FDA and HPFB/TPD you can repeat a sample based on PK grounds and report the repeated value – if you have an SOP for the entire procedure.
Bad luck with EMA (and countries adapting its rules: Australia & New Zealand).

Did you compared the IS response of the original value with the repeat’s? If in the original analysis IS addition was incomplete, you will get a higher analyte/IS ratio → concentration.

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Helmut Schütz

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Complete thread:

PK profile outlier avinash 2013-05-02 14:48
- IS response?Helmut 2013-05-02 14:56
  - IS response? avinash 2013-05-02 15:09
    - DB Summary Table 9 Helmut 2013-05-02 15:17
      - DB Summary Table 9 AngusMcLean 2013-05-15 00:38