Olivbood ☆ France, 2019-06-14 12:42 (1774 d 20:09 ago) Posting: # 20325 Views: 2,655 |
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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] |
Helmut ★★★ Vienna, Austria, 2019-06-14 22:43 (1774 d 10:08 ago) @ Olivbood Posting: # 20327 Views: 2,216 |
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Hi Olivbood, ❝ 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. Correct. ❝ 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? Correct, again. I both cases I would include a bit more subjects to be protected against eventual dropouts. I guess the FDA wouldn’t be amused to get a study in 11 subjects although the guidance clearly states “12 enrolled”. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |