Lagarto PA, Torres AL, Carrillo DC, Gabilondo RT

Language: Spanish
References: 6
Page: 191-201
PDF size: 84.16 Kb.

ABSTRACT

Introduction: a biological test is used to measure local anesthesia time of a drug or an active principle under research.
Objective: to validate the measuring method of local anesthesia time for the evaluation of generic drug with this pharmacological action.
Methods: accuracy, precision, robustness, linearity, parallelism and specificity were evaluated according to the methodology described in 41-2007 Regulation of the Center for the State Control of Drug Quality (CEDMED).
Results: in the accuracy test, no significant differences were observed between the results of tested sample and the reference material at the 3 tested doses. Variation Coefficients was less than 50 % in the repeatability test. There were no significant differences between the precision values of two different analysts at different times and in three different batches. The specificity test showed that excipients or auxiliary substances in the formulation did not interfere with the evaluation of the product. The method was linear in a 50-120 % range of concentrations, with acceptable accuracy and precision, and parallelism. The robustness test yielded no differences in the results obtained after changing various parameters.
Conclusions: biological method proved to be accurate, precise, specific, linear and robust.

REFERENCES

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2. CECMED. Validación de Métodos analíticos. Regulación Nº 41-2007. La Habana: MINSAP; 2007.

3. Martindale: The Complete Drug Reference. Lidocaine Hydrochloride. 36th ed. London: The Pharmaceutical Press; 2009. [CD-rom].

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5. USP 32. General Chapter 1225, Validation of compendial methods, United States Pharmacopeia XXXII, Rockville: United Pharmacopoeial Convention, Inc.; 2009. [CD-rom].

6. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: Text and Methodology, Q2(R1). Geneva: ICH; 2005.