Bioequivalence and Bioavailability Forum • Co-dosed compounds stability effect

Co-dosed compounds stability effect [Regulatives / Guidelines]

posted by jchapdelaine – 2010-11-17 20:54 (5703 d 07:56 ago) – Posting: # 6159
Views: 3,616

Hi Marko,

I do have a bit more information on this subject as I spoke to the FDA a few months ago concerning this at the BSAT-APA conference.

❝ Is there indeed a full validation needed in such cases?

There is no stated requirement for a full validation, however it is not sufficient to demonstrate lack of interference. The stability of the quantitated analytes must also be re-evaluated.

FDA is also looking to provide more information on this at upcoming conferences.

Regards,
John

Complete thread:

Co-dosed compounds stability effect jchapdelaine 2010-05-10 17:03
- Co-dosed compounds stability effect Debbie 2010-05-11 17:13
  - Co-dosed compounds stability effect Dr_Dan 2010-05-12 08:53
    - Co-dosed compounds stability effect Ohlbe 2010-05-12 10:13
      - Co-dosed compounds stability effect jchapdelaine 2010-05-12 19:40
- Co-dosed compounds stability effect moblak 2010-11-17 15:53
  - Co-dosed compounds stability effectjchapdelaine 2010-11-17 19:54
    - Co-dosed compounds stability effect + drugs and metabolites moblak 2010-11-18 10:37
      - Glucuronides Helmut 2010-11-18 15:49
      - Co-dosed compounds stability effect + drugs and metabolites jchapdelaine 2010-11-19 20:36