T/R 90% to 110% for sample size estimation [Regulatives / Guidelines]
Dear all,
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.
As per EMA guideline (2010) "batches should not differ more than 5%" so taking 10% difference in T/R ratio is considerable.
Also if I am taking the T/R ratio=110% I am getting sample size around 50 (without dropout) but many studies I found for this drug is around 40 even our earlier study had 42. then in that case if am exceeding sample size will it considered as a forced bioequivalence?
Earlier study results used for sample size estimation
LnCmax ratio=110.3 (90%CI- 101.06-120.54) CV=24.3.
Please reply.
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.
As per EMA guideline (2010) "batches should not differ more than 5%" so taking 10% difference in T/R ratio is considerable.
Also if I am taking the T/R ratio=110% I am getting sample size around 50 (without dropout) but many studies I found for this drug is around 40 even our earlier study had 42. then in that case if am exceeding sample size will it considered as a forced bioequivalence?
Earlier study results used for sample size estimation
LnCmax ratio=110.3 (90%CI- 101.06-120.54) CV=24.3.
Please reply.
—
Kumar Naidu
Kumar Naidu
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 estimationkumarnaidu 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 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 estimationkumarnaidu 2013-11-26 05:36
- Optimism Helmut 2013-10-14 17:50
- ∆ <5% ⇒ T/R 95% Helmut 2013-10-10 16:08