Line extension [Design Issues]

posted by Mikkabel – Belgium, 2018-01-24 11:17 (2273 d 01:23 ago) – Posting: # 18285
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❝ 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,

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