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RegisterFood effects [Design Issues]
Dear Mr Prasad,
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.
❝ 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.
Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Complete thread:
- Food effects prasad.v 2021-06-08 08:35 [Design Issues]
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- Food effectsdrgunasakaran1 2021-06-09 06:06
Ing. Helmut Schütz