Peak time bioequivalence studies

For bioequivalence studies, the two formulations of same drug is administered orally as single dose. Figure 1.4.2 shows that in the study the different parameters are obtained. Firstly the peak height which represents the highest concentration of the drug reached in the blood at a particular time i.e. time of peak concentration. The area... 

For many pharmaceutical compounds administered as transdermal drug delivery systems, absorption can be assessed by determining the area under the curve (AUC) of the plasma concentration-time profile, the peak plasma flux, and time of peak flux, much as it is for determining bioavailability from oral and other routes of administration. These are classical metrics of biophar-maceutical bioequivalence studies and are extensively covered in other texts... 

The parameters evaluated in a bioequivalency study are (AUC)q, peak plasma concentrations and peak time. 

In assessing bioequivalency, in addition to (AUC)q, the peak time and peak plasma concentration of each dosage form under consideration would need to be compared. Moreover, in a bioequivalency study, these comparisons are not done by calculating simple ratios. Instead they are performed by rather sophisticated statistical techniques, as described in Chapter 7. The calculation below of peak time (fmax) and peak plasma concentration (Cp)max for the tablet and capsule dosage forms performs a very simple comparison of the values. 

Bioequivalence. This is the statistical equivalence between the generic and the standard (brand name) formulation of drug for the "big three" parameters peak plasma drug concentration [(Cp)max]/ time of peak plasma drug concentration (tmax)/ and area under the plasma drug versus time concentration curve (AUC). The FDA looks at the data of the study and decides whether these have proved bioequivalence or not. 

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