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RegisterWater requirement in Fed state studies [Study Performance]
Hi,
Per EMEA's current BE guidance (GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE)
'It is recommended that water is allowed as desired except for one hour before and one hour after drug administration and no food is allowed for at least 4 hours post-dose.'
And for fed state studies it is also required that
'subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes.
So if water is consumed while taking high fat breafast, will it not be violation of the first statement, as this happens during one hour before drug administration?
If not, do we need to standardise the volume of water given for high fat breakfast?
Your advise will be highly appreciated!
Thanks
Max
Per EMEA's current BE guidance (GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE)
'It is recommended that water is allowed as desired except for one hour before and one hour after drug administration and no food is allowed for at least 4 hours post-dose.'
And for fed state studies it is also required that
'subjects should start the meal 30 minutes prior to administration of the drug product and eat this meal within 30 minutes.
So if water is consumed while taking high fat breafast, will it not be violation of the first statement, as this happens during one hour before drug administration?
If not, do we need to standardise the volume of water given for high fat breakfast?
Your advise will be highly appreciated!
Thanks
Max
Complete thread:
- Water requirement in Fed state studiesClinResBE 2014-09-26 18:34
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- Water requirement in Fed state studies drgunasakaran1 2014-10-01 18:29
Ing. Helmut Schütz