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

posted by Olivbood – France, 2019-06-14 10:42 (731 d 18:41 ago) – Posting: # 20325
Views: 1,769

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:

Activity
 Admin contact
21,518 posts in 4,498 threads, 1,524 registered users;
online 23 (0 registered, 23 guests [including 7 identified bots]).
Forum time: Tuesday 05:23 CEST (Europe/Vienna)

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

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