the basis of T/R in the Protocol [Regulatives / Guidelines]
Hi Helmut and All,
Do you state in the protocol the reasons why did you choose the exact T/R ratio (not default 95% setting)?
❝ ❝ If in my earlier studies I am getting T/R ratio= 110% means >5% difference then for planning another study for another market should I go with the T/R=110% or 95% for sample size estimation.
❝ The former. Although with another reference product the ratio might be better, without a pilot study I would suggest a conservative approach.
Do you state in the protocol the reasons why did you choose the exact T/R ratio (not default 95% setting)?
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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 Protocolmittyri 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 Protocol mittyri 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 Protocol mittyri 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