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Query: when you are doing a fed BE study if any subject not able to
complete the meals (high fat high calorie breakfast), till what
extent you will allow him to continue in the study. A person not able
to consume 10% of the calorie or 50% of the calorie or he should
complete the meal, then only he will be allowed to continue in the
study.
Regards,
Dr.Shiva Murthy.N
Head-Clinical Operations
Fortis Clinical Research Limited
Faridabad
Ph-0129-4090900
Fax-0129-4090924
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Sir,
You need to weight and measure the food content left by him/her. If
the consumed calories are > 800 Kcal then you can ask the subject to
continue in the study. If the consumed calories are <800 Kcal you
have to withdraw the subject with the reason of non-compliance with
study (if it is USFDA submission study).
Thanks with regards,
Chintan Mehta
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The following message was posted to: PharmPK
sir
May i request for the refernce/web link for the same.
Thanks in advance
Cheers
Himanshu Narang
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