Pharmacokinetic basis of bioequivalence

Pharmacokinetic basis of bioequivalence

Bioequivalent products are similar dosage forms that contain the same amount of the same active drug and have the same rate and extent of drug absorption.

The three parameters used in determining the bioequivalence of different drug products are:

1- Maximum drug conc (Cpmax):

The highest drug conc achieved in the systemic circulation after drug administration.

Cpmax

tmax

AUC

2- Time to maximum drug conc (tmax):

The length of time required to achieve the maximum drug concentration.

3- Area under the curve (AUC):

The integral of the plasma concentration-time profile from time zero to infinity.