Type I error inflation caused by batch-to-batch variability of Reference? [Design Issues]

posted by nobody – 2016-10-20 12:00 (2716 d 11:25 ago) – Posting: # 16738
Views: 8,836

Good morning everybody out there!

I'm a little slow this morning, not enough caffeine I guess, maybe someone can enlighten me:

Sandoz wants more strict BE requirements for generics to Advair Diskus 100/50 (they have tried to get marketing authorization, but apparently did not succeed yet)

http://freepdfhosting.com/56dc6751dc.pdf

on page two states:

"1) Type I error rate is adequately controlled in PK bioequivalence testing, including accounting for Type I error rate inflation caused by batch-to-batch variability of the RLD"

Hmm. Type I inflation due to high variability of Reference? Do they mean that you "by chance" ( :-D ) pick the "right" batch to show equivalence and get away with it?

They published this here on batch-to-batch variability of Reference:

https://www.ncbi.nlm.nih.gov/pubmed/27037630

...which shows substantial variability from batch to batch.

Do I get it right?

Kindest regards, nobody

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