Biology & Medicine Case Reports

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Biology & Medicine Case Reports 44 7897 074717

Bioequivalence Innovations

Bioequivalence may be a term in pharmacokinetics wont to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two drugs are bioequivalent it means they might be expected to be, for all intents and purposes, the same. In determining bioequivalence between two drugs like a reference drug (Brand) and potential to be test drug (marketed generic drug), pharmacokinetic studies are conducted whereby, each of the drugs are administered during a cross over study to volunteers subjects (healthy individuals). Serum/plasma are obtained at regular intervals and assayed for parent drug (metabolites) concentration. Blood concentration levels are neither feasible or possible to match the 2 drugs, then pharmacodynamic endpoints instead of pharmacokinetic end points are used for comparison. For a pharmacokinetic comparison, the plasma concentration data are wont to assess key pharmacokinetic parameters like area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lag time (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics. If 90% Confidence interval for the ratio of the geometric least square means of natural log transformed Cmax, AUC0-t and AUC0-inf of Test and Reference drugs are within 80.00% to 125.00%, then bioequivalence are going to be establish.

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