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Dear all,
Have any one of you gotten approval for the bioequivalence study with
CI for all 3 parameters Cmax, AUC0-t, AUC0-inf in wider range of
75-133% for any regulatory authorities?
In those conditions how to prove the safety and efficacy of the
formulation as asked by the regulatories?
thru literature or thru in house clincal study?
please clarify
regards,
Muhiyideen
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dear ,
criteria for Cmax, AUC0-t, AUC0-inf in wider range of
75-133% is been specified in OGD recommandation(US FDA) for specific
drugs having narrow therapeutic index.
even regulatory guidelines of anvisa and eu showing it.
if you want to go with these specification then you should defined it
well in advance in protocol.
safety and eficiecy could be proved in same way of 80-125, but in
these with wider range
i hope this will help you.
regards,
gaurav shah,
RQA,sparc
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The following message was posted to: PharmPK
Dear Muhiyideen
European authorities won't accept the wider range for AUC's, especially
if you are dealing with a generic procedure. The only way is to prove
efficacy and safety through clinical studies (pharmacodynamic) with the
test formulation.
Best regards
Nuno Silva
Faculty of Pharmacy, U.L.
Biopharmaceutics and Pharmacokinetics Dept.
Av. Prof. Gama Pinto
1649 003 Lisbon / Portugal
E-mail: nmens.-a-.ff.ul.pt
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