Minimal Sample Size for Food Effect Study [Regulatives / Guidelines]

posted by Olivbood – France, 2019-06-14 10:42 (1160 d 07:13 ago) – Posting: # 20325
Views: 2,283

Hello everyone,

I have a relatively quick question in regards to the FDA guideline "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" dated February 2019.

The guideline specifies that "At a minimum, 12 subjects should be enrolled in each treatment arm." I deduce from it that this is the minimal sample size considering a parallel design study.
Alternatively, for a classic 2x2 cross-over study the minimal sample size should be 12 subjects in total since each subject will experience both fed and fasted status.

Is my understanding correct?

Many thanks,

Olivbood


Edit: Guidance linked. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 5 (2 registered, 3 guests [including 2 identified bots]).
Forum time: Wednesday 17:55 CEST (Europe/Vienna)

There is no point in being precise when you don’t know
what you’re talking about.    attributed to John Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5