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

posted by Olivbood – France, 2019-06-14 10:42 (474 d 09:07 ago) – Posting: # 20325
Views: 1,434

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,


Edit: Guidance linked. [Helmut]

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