the basis of T/R in the Protocol [Regulatives / Guidelines]
Dear Helmut,
Thank you for the inestimable contribution to my (and others) knowledge in BEQ
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)
Nice example
In this case, did you "hit the jackpot" (by the luck CI's were in the borders)?
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)?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
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
- 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 15:01
- 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 13:53
- T/R 110% Helmut 2013-11-30 14:02
- T/R 90% to 110% for sample size estimation kumarnaidu 2013-11-26 05:36
- Optimism Helmut 2013-10-14 17:50
- ∆ <5% ⇒ T/R 95% Helmut 2013-10-10 16:08