Food effects [Design Issues]

posted by prasad.v – India, 2021-06-08 08:35 (51 d 18:13 ago) – Posting: # 22392
Views: 455

As per guidelines, subjects should start the recommended meal 30 minutes prior to administration of the drug product. Study subjects should eat this meal in 30 minutes or less; however, the drug product should be administered 30 minutes after start of the meal.

But if one subject completed his breakfast within 30 minutes but dosing was done beyond 30 minutes (31 minutes or above). Is it justifiable or any effect on the concentrations and outcome of the study.

Eg., Break fast start time 08:00 AM and end time 08:28 AM
       Dosing time 08:35 AM

Thanks and regards,
Prasad


Edit: Category changed; see also this post #1[Helmut]

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