Resumo

VILLCA JIMENEZ, Tania Mercedes  e  BLANCO ESCOBAR, Yetzabel Alelí. Evaluation of the Therapeutic and Chemical Equivalence of  Glibenclamide between innovative and generic drugs in experimental animals subjects (rabbits). BIOFARBO [online]. 2008, vol.16, n.1, pp. 84-91. ISSN 1813-5363.

A pharmaceutical medical problem in Bolivia is the replacement of innovative medicines by similar medicines (replicas made and manufactured by other laboratories), which must have scientific evidence that demonstrates the pharmacokinetic performance and especially the bioavailability of the susbtitute drug  in relation to the original medicine.  The aim of this study was to determine the chemical and therapeutic equivalence of glibenclamide, taking as a refference the innovative product, and comparing it with two generic drugs, one national and one imported, through animal testing, using a crossover design, over a period of dosing intervals of time in relation to the average life of the drug. The results of the assessment of chemical equivalence showed that the 3 drugs comply with the specified concentration specified by Pharmacopoeia USP XXVI. The results of the evaluation of therapeutic equivalence using the statistical method of least significant difference were similar to the generic product No. 1, and not for the generic product No. 2, and what`s more, taking into account the limits of statistical confidence, none of them can be considered bioequivalent. We concluded that generic drugs are chemical equivalents to innovative product, but they are not therapeutic equivalents.

Palavras-chave : therapeutic equivalence; glibenclamide; generic drug; innovating drugs.