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RegisterMinimal Sample Size for Food Effect Study [Regulatives / Guidelines]
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]
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:
- Minimal Sample Size for Food Effect StudyOlivbood 2019-06-14 10:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Parallel: 2×12, Xover: 12 Helmut 2019-06-14 20:43
Ing. Helmut Schütz