Abstract

CASTILLO AGUILAR, Beatriz  and  GONZALEZ HERNANDEZ, Rolando. Protocolo de validación de métodos analíticos para la cuantificación de fármacos. Rev Cubana Farm [online]. 1996, vol.30, n.1, pp. 0-0. ISSN 1561-2988.

A summary of the general considerations fot the formulation of a validation protocol of the analytical methods used in drug quantitative determination in a raw material form, or in formulations and firmness studies. The validation process is fully described; it includes the necessary requirements for the usage of raw materials, reference materials, supplying, personnel, and determination of linearity, preciseness, exactness, and selectiveness (with the statistical processing of experimental results, and acceptance criteria), as well as the presentation of outcomes in the validation final report.

Keywords : CHEMISTRY, PHARMACEUTICAL; DRUG STABILITY; CHEMISTRY, ANALYTICAL; TECHNOLOGY, PHARMACEUTICAL..