Bioequivalence and Bioavailability Forum

Dose proportionality and BE [Design Issues]

posted by Ohlbe – France, 2011-11-04 11:19 (4930 d 18:16 ago) – Posting: # 7604
Views: 7,886

Dear Helmut and Sciguy,

I just noted this in a Q&A on the CMDh web site. See question 8a, on the situation when the relevant strength of the reference product is no longer marketed:

In general the cumulative strength of the reference product should be the same as the strength that the applicant has applied for, thus maintaining the direct link with the reference product. However it may be justified to use different strengths when pharmacokinetics are linear and a potency correction is performed. This would apply if the different strengths or pharmaceutical forms of the reference product are part of the same Global Marketing Authorisation and the general biowaiver criteria as outlined in section 4.1.6 of the Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev.1/Corr**) should be met for the test product when relevant. The acceptability of using a different strength or pharmaceutical form of the reference medicinal product should also be discussed with the competent authority of the country where the reference product is authorised.

To summarise: it may be acceptable, but ask for scientific advice first

Regards
Ohlbe

Complete thread:

• Dose proportionality and BE sciguy 2011-11-02 16:52 [Design Issues] 
  • Dose proportionality and BE Helmut 2011-11-02 21:11
    • Dose proportionality and BE sciguy 2011-11-03 20:30
      • Dose proportionality and BE Helmut 2011-11-03 21:06
        • Dose proportionality and BEOhlbe 2011-11-04 10:19
        • Dose proportionality and BE sciguy 2011-11-04 15:34
          • Dose proportionality and BE Helmut 2011-11-04 16:25
            • Dose proportionality and BE sciguy 2011-11-04 19:18
              • Dose proportionality and BE Helmut 2011-11-04 19:55