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Dear all,
Why in BE study, usually higher dose is selected ?
It may be due to regulatory requirement !
If so is it ethically right to expose, human beings to higher dose -
Main Concern will be Adverse Event !
Please comment on this.
Regards,
Dr.Sridhar
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The following message was posted to: PharmPK
Dear Dr. Sridhar
Usually higher doses are selected to avoid to do BE study in lower
strengths or to get biowaier from regulatory authorities. If the
higher strength of the drug having undesirable effect in volunteers
you can go for lower stengths.
I hope this answers your query.
Best Regards,
Shankara Narayanan
Sitec Labs Pvt Ltd,
Mumbai.
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