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Is BE study necessory for Dose wieght proportionate formulation? ( if BE data for one strength is available)
If No, then BE data of which strength is to be considered? ( lower or higher srength )
Thanks
Shital p.
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The following message was posted to: PharmPK
To,
shital,
kindly see the guidance for industry SUPAC. you will get answer from
that guidance.
regards
dr haresh patel
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Dear Shital,
Check the FDA Individual Product Bioequivalence recommendations for the drug molecule which you are considering for new dose weight proportionate formulation.
Considering Biowaiver for higher or lower strengths will depends upon the molecule and you can find the appropriate strength for conducting Bioequivalence study in the FDA Individual Product Bioequivalence Recommendations.
Check out the link for FDA Individual Product Bioequivalence Recommendations.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances /ucm075207.htm
Thanks & Regards,
Dr.S.Gunasakaran, MD
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