Line extension [Design Issues]
❝ Luckily you are not exceeding the recommended dose of the originator. Hence, I would opt for a simple line extension (T2 vs. 2×T1) since you can expect a better match than in BE – which is possible as well (T2 vs. 2×R).
❝ I don’t see how you could perform a dose-proportionality study with just two levels (zero degrees of freedom).
Hi Helmut,
Thank you for your quick reply!
I would also opt for a simple Pk study (T2 versus 2*T1) but do you have any idea to which guidelines I can refer to justify the rationale of the study and in particular the choice of the comparator (T1 instead of the originator).
Regarding the dose proportional study, I meant a PK study (T1 vs T2) and the results corrected by the dose should be compared.
Kind regards,
Complete thread:
- Choice of comparator Mikkabel 2018-01-23 17:29 [Design Issues]
- Line extension Helmut 2018-01-23 17:40
- Proportionality and regression mittyri 2018-01-23 18:30
- Proportionality and regression Helmut 2018-01-23 18:41
- Line extensionMikkabel 2018-01-24 10:17
- Type II variation Helmut 2018-01-24 11:56
- Proportionality and regression mittyri 2018-01-23 18:30
- Line extension Helmut 2018-01-23 17:40