Roger Berger on Stephen Senn’s “Blood Simple” with a response by Senn (Guest posts)

Roger BergerRoger L. Berger

School Director & Professor
School of Mathematical & Natural Science
Arizona State University

Comment on S. Senn’s post: Blood Simple? The complicated and controversial world of bioequivalence”(*)

First, I do agree with Senn’s statement that “the FDA requires conventional placebo-controlled trials of a new treatment to be tested at the 5% level two-sided but since they would never accept a treatment that was worse than placebo the regulator’s risk is 2.5% not 5%.” The FDA procedure essentially defines a one-sided test with Type I error probability (size) of .025. Why it is not just called this, I do not know. And if the regulators believe .025 is the appropriate Type I error probability, then perhaps it should be used in other situations, e.g., bioequivalence testing, as well.

Senn refers to a paper by Hsu and me (Berger and Hsu (1996)), and then attempts to characterize what we said. Unfortunately, I believe he has mischaracterized. Continue reading

Categories: bioequivalence, frequentist/Bayesian, PhilPharma, Statistics | Tags: ,

Stephen Senn: Blood Simple? The complicated and controversial world of bioequivalence (guest post)

Stephen SennBlood Simple?
The complicated and controversial world of bioequivalence

by Stephen Senn*


Those not familiar with drug development might suppose that showing that a new pharmaceutical formulation (say a generic drug) is equivalent to a formulation that has a licence (say a brand name drug) ought to be simple. However, it can often turn out to be bafflingly difficult[1]. Continue reading

Categories: bioequivalence, confidence intervals and tests, PhilPharma, Statistics, Stephen Senn

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