Posting: # 19288
Please let me know the feasibility of conducting study with 3 arms where 1 arm is test product, 2nd arm is US (RLD) & third arm is UK (RLD) keeping in mind whether this is permitted & acceptable to both the regulatory authorities.
Edit: Category changed; see also this post #1. [Helmut]
Posting: # 19289
» […] study with 3 arms where 1 arm is test product, 2nd arm is US (RLD) & third arm is UK (RLD)
There are no “reference-listed drugs” in Europe.
» whether this is permitted & acceptable to both the regulatory authorities.
Sure. For the evaluation I suggest avoiding a pooled analysis (i.e., based on a common variance in ANOVA) but exclude the respective other treatment from the analysis (whilst keeping the codes for period and sequence) – resulting in two incomplete block designs (one for the comparison of T with one of the European originator’s products anf the other one for the comparison of T with the US RLD).
See also the EMA’s BE-GL, Section 4.1.8 …
In studies with more than two treatment arms (e.g. a three period study including two references, one from EU and another from USA […]), the analysis for each comparison should be conducted excluding the data from the treatments that are not relevant for the comparison in question.… and this post.
Don’t forget that for the FDA the ABE-model treats subjects as a random effect (e.g., by SAS
The quality of responses received is directly proportional to the quality of the question asked. ☼
Posting: # 19291
Thank you for your valuable suggestions/opinion.