Bioequivalence and Bioavailability Forum

the basis of T/R in the Pro­tocol [Regulatives / Guidelines]

posted by mittyri  – Russia, 2014-03-14 22:08 (4130 d 11:39 ago) – Posting: # 12631
Views: 7,497

Dear Helmut,

Thank you for the inestimable contribution to my (and others) knowledge in BEQ

❝ By “pilot” I meant studies the sponsor performed or have access to in an acquired dossier. Only such studies can be assesses for the quality of data (clinical performance, bioanalytics, …).

If I understand right, you state in the protocol phrases like that:
According to the earlier performed by sponsor study, T/R ratio could be assumed as 0.92%.
How could I prove to the assessor that "pilot" study is really performed? As a sponsor I can write that I performed the study in another market, but assessment report isn't published (no links)

❝ Once the Austrian agency AGES did not like the sample size we stated in the protocol: “It is not acceptable to perform the study in only 16 sub­jects when most of the BE studies of XYZ are performed in more than 30.” Hey, it was a pilot study… Case closed.

Nice example
In this case, did you "hit the jackpot" (by the luck CI's were in the borders)?

Complete thread:

• Difference between test and reference nlpati 2013-10-10 13:40 [Regulatives / Guidelines] 
  • Assayed content Helmut 2013-10-10 14:46
  • Difference between test and reference jag009 2013-10-10 15:19
    • ∆ <5% ⇒ T/R 95% Helmut 2013-10-10 16:08
      • ∆ <5% ⇒ T/R 95% nlpati 2013-10-11 04:37
      • ∆ <5% ⇒ T/R 95% jag009 2013-10-13 21:02
        • Optimism Helmut 2013-10-14 17:50
          • T/R 90% to 110% for sample size estimation kumarnaidu 2013-11-26 05:36
            • T/R 110% Helmut 2013-11-30 14:02
              • T/R 110% kumarnaidu 2013-12-02 05:35
              • the basis of T/R in the Pro­tocol mittyri 2014-03-14 08:10
                • the basis of T/R in the Pro­tocol Helmut 2014-03-14 13:53
                  • the basis of T/R in the Pro­tocol mittyri 2014-03-14 14:31
                    • the basis of T/R in the Pro­tocol Helmut 2014-03-14 15:01
                      • the basis of T/R in the Pro­tocolmittyri 2014-03-14 21:08
                        • the basis of T/R in the Pro­tocol Helmut 2014-03-14 23:02