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ClinResBE ☆ India, 2014-09-26 20:34 (3879 d 21:59 ago) Posting: # 13598 Views: 5,586 |
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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 |
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drgunasakaran1 ★★  2014-10-01 20:29 (3874 d 22:04 ago) @ ClinResBE Posting: # 13635 Views: 4,308 |
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Dear Mr Max, ❝ So if water is consumed while taking high fat breakfast, 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? Usually, eight ounces of milk will be provided along with high fat, high calorie breakfast. If we capture the intake of water in the protocol along with the high fat, high calorie breakfast intake, then it will not be deviation/violation. But, you need to standardize the volume of water to be given along with the fed breakfast to avoid any regulatory query. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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