SR formulations [General Sta­tis­tics]

posted by hirenpharm – Ahmedabad, 2007-01-20 11:05 (6096 d 16:49 ago) – Posting: # 476
Views: 13,204

Dear all,

Please suggest.
If a single dose BE study of a SR product Vs SR product... we find AUC0-last failing but AUC0-T(Tau)(say 0-24 hrs) passing and Cmax and AUC0-inf is also passing (fast and fed) and no need for steady state.

Can be seek TGA approval for the study?

Which objections are anticipated?


Dr. Hiren Mehta

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