prasad.v
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India,
2021-06-08 06:35
(4 d 04:41 ago)

Posting: # 22392
Views: 191
 

 Food effects [Design Issues]

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]
drgunasakaran1
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2021-06-09 04:06
(3 d 07:11 ago)

@ prasad.v
Posting: # 22394
Views: 84
 

 Food effects

Dear Mr Prasad,

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

As per the regulatory guidance, it is suggested to administer the investigational product 30 min after the high fat, high calorie breakfast.
If it is a cross over study, and the deviation of 5 min occurred in period I of the study, we can follow the same 5 min deviation in period II to match the pharmacokinetic profiling in both the periods after IP administration and regulatory may accept the justification for the deviation.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
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