Resumen

GANOZA-GASCO, Frizzi J. et al. In vitro bioequivalence of psychotherapeutics acquired by the Peruvian state: case, Carbamazepine and Diazepam. Mem. Inst. Investig. Cienc. Salud [online]. 2025, vol.23, n.1, e23122510.  Epub 30-Dic-2025. ISSN 1812-9528.  https://doi.org/10.18004/mem.iics/1812-9528/2025.e23122510.

Bioequivalence assessment plays a fundamental role in determining the quality and efficacy of generic drugs. In the specific case of psychotropic drugs, such as carbamazepine (CBZ) and diazepam (DZP), their in vitro biopharmaceutical equivalence is a priority. The objective was to determine the in vitro bioequivalence of carbamazepine and diazepam purchased by the Peruvian government. Quality control, method validation, and determination of dissolution profiles compared to the innovator drug were performed using the similarity factor (f₂). Significant differences were found in quality controls; the method was successfully validated; and there are more significant differences in the dissolution profile of carbamazepine than diazepam. In vitro bioequivalence with the innovator was only demonstrated by the multisource batch of diazepam acquired by EsSalud.

Palabras clave : Bioavailability; biowaiver; dissolution profile; validation.

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