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The following message was posted to: PharmPK
Dear All,
Can anyone suggest for purpose of doing BE study on lower strength as
well as highest strength.
Because sometimes sponsor ask for BE study of lower strength (for
example 150 mg) of simple molecule.
Though it is not a complicated or non-linear kinetics or narrow
therapeutic product or highly variable product.
And again he wishes to do BE study of highest strength also.
So why they don't go directly for highest strength (for example 300
mg), in case where they will get biowaiver for lower strength.
Your suggestions will be highly appreciated.
Thanks
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The following message was posted to: PharmPK
Dear concerned,
There may be two trigger points of doing BE study on lower as well as
higher strength.
1. It is recommended from Office of generic drug especially for USFDA
studies.
2. FDA give recommendation for those particular molecules in which
formulation charectiristics are more prominently distinguished on
lower strength.
Therefore in case of pilot study formulator may get better idea from
lower strengths.
Regards
Anuj Saini
Research Scientist
Pharmacokinetic
Jubilant Organosys
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Although the kinetics are linear but if the formulation is not dose-
proportionate, BE studies has to be done on different strengths.
Cordially,
Dr. Renu Jain
Research Associate
Clinical Research & Regulatory Affairs
Torrent Research Centre,
Village: Bhat, Dist: Gandhinagar - 382 428
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