Food effects [Design Issues]

posted by drgunasakaran1  – 2021-06-09 08:06 (986 d 18:58 ago) – Posting: # 22394
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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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