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

posted by Dr_Dan  – Germany, 2016-10-20 14:20 (3041 d 06:55 ago) – Posting: # 16741
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❝ 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?


If you "by chance" picked the "right" RLD batch to show equivalence, do you also need to show in-vivo that you picked the "right" test product batch? How would you define "right"?

Kind regards and have a nice day
Dr_Dan

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