Resumo

MARTINEZ, Lázara  e  SELMAN, Epifanio. Centro para el control estatal de la calidad de los medicamentos requisitos regulatorios para los medicamentos antimicrobianos. Rev Cubana Farm [online]. 1997, vol.31, n.3, pp. 199-205. ISSN 1561-2988.

It is made a bibliographic review about the general characterisitics of antimicrobics, the peculiarities of the microbiological evaluation, and the regulatory demands of this type of drugs in other countries. The investigations that should be included in the preclinical record and considered as part of the final version of the regulatory requisites for the request of the Register of Antimicrobial Drugs are proposed.

Palavras-chave : ANTIBIOTICS [standards]; DRUG QUALITY; CUBA.