Our formulation is acheving t max in 48 hrs where as the reference formulation is attaining in 4 days, although our formulation attain T max quickly but our C max is almost same as the reference.
well for drugs mainly antibacterials early cmax is important to combat bacterial infections. Again this varies with the drug being concentration or time dependent
For studies to determine bioequivalence of sustained release preparation in single dose studies , AUC(0-τ) and Cmax,should be analysed.
A statistical evaluation of tmax is not required. However, if rapid release is claimed to be clinically relevant and of importance for onset of action or is related to adverse events, there should be no apparent difference in median tmax and its variability between test and reference product.
I think, it really depends on therapeutic requirement of the formulation.
For example, if the active ingredient is time dependent antibiotic, time above MIC is nearly the most important one (not Tmax)
For sustained release formulation, personally the time above MEC should be much considered than T max
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