Bioequivalence and Bioavailability Forum

Revalidation? [Study As­sess­ment]

posted by Helmut  – Vienna, Austria, 2019-12-18 18:40 (1377 d 15:07 ago) – Posting: # 21000
Views: 2,995

Hi Mittyri,

❝ […] approach when the method is revalidated taking into account Cmax values of that subjects (LLOQ should be less than 5% min Cmax of those) and then the affected volunteers are reanalyzed (of course till the moment of database lock). What do you think?

Yes, why not? As long as the data are not unblinded, it should not hurt. However,

❝ Recently we submitted a BE study to EU…

(my emphasis)

Hence, it can be just another kind of sensitivity analysis.

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Posting # 21,000.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• BEQ inquiry from health authority Aymanmy 2019-12-18 08:51 [Study As­sess­ment] 
  • BEQ inquiry from health authority Dr_Dan 2019-12-18 14:46
  • Method not sensitive enough Helmut 2019-12-18 15:16
    • Revalidation? mittyri 2019-12-18 16:52
      • Revalidation?Helmut 2019-12-18 17:40
    • Method not sensitive enough Aymanmy 2019-12-18 17:58
      • Method not sensitive enough Helmut 2019-12-18 18:54
        • Method not sensitive enough Aymanmy 2019-12-19 08:21