Bioequivalence


The scientific basis upon which brand-name drugs are compared to their generic equivalents is the bioequivalence study of the drug. Studies must be conducted to ensure the two products do not differ in safety, efficacy, and bioavailability when administered at the same dosages. These studies are conducted under the protocols of Agência Nacional de Vigilância Sanitária (ANVISA).

Bioequivalent:
Two medicinal products are bioequivalent if they are pharmaceutically equivalent or alternative and if their bioavailabilities (rate and extent) after administration in the same molar dose are similar to such degree that their effects, regarding both efficacy and safety, are essentially the same.
 

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