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

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
Kindest regards, nobody
Complete thread:
- Type I error inflation caused by batch-to-batch variability of Reference?nobody 2016-10-20 10:00 [Design Issues]
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:06
- Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 12:14
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:20
- Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 12:27
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:49
- Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 14:27
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:49
- Type I error inflation caused by batch-to-batch variability of Reference? nobody 2016-10-20 12:27
- Type I error inflation caused by batch-to-batch variability of Reference? DavidManteigas 2016-10-21 10:44
- Type I error inflation caused by batch-to-batch variability of Reference? Helmut 2016-10-24 17:12
- Type I error inflation caused by batch-to-batch variability of Reference? Dr_Dan 2016-10-20 12:06