Tuesday, June 1, 2021

BIO-EQUIVALENCE

 

BIO-EQUIVALENCE



AUC of the plasma concentration time curves of same drug X, but of different oral formulations A, B and C, are almost same.

So the extent of absorption of the three formulations are same.

However, they are not bio-equivalent.

Reason- The rate of absorption is not same.

For bio-equivalence, both rate and extent of absorption should not be significantly different.

AUC for A and B are similar with respect to both the rate and extent of absorption. AUCs are similar in shape and size. Therefore, formulations A and B are bio-equivalent.

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