Numeral 13 — NOM-177-SSA1-2013, Que establece las pruebas y procedimientos para demostrar que un medicamento es intercambiable. Requisitos a que deben sujetarse los Terceros Autorizados que realicen las pruebas de intercambiabilidad. Requisitos para realizar los estudios de biocomparabilidad.

13 Bibliografía

13.1 Ley General de Salud.

13.2 Reglamento de Insumos para la Salud.

13.3 Reglamento de la Ley General de Salud en Materia de Investigación para la Salud.

13.4 Reglamento de la Comisión Federal para la Protección contra Riesgos Sanitarios.

13.5 Declaración de Helsinki de la Asociación Médica Mundial. Principios éticos para las investigaciones

médicas en seres humanos. 2000, con sus enmiendas en 2002, 2004 y 2008.

13.6 ISO GUIA 30, Terms and definitions used in connection with reference materials.

13.7 ISO 9001: 2008. Quality management systems-Requirements.

13.8 Shrikant, D. Pharmaceutical Research, 1992; 9(4).

13.9 Karnes, H. T., Shiu, G. y Shah, V. P. Bioanalyt ical Method Validation. Pharmaceutical Research,

1991:9:421-426.

13.10 Shah V,. Midha K, Findlay J, Hill H, Hulse J, I Mc Gilveray I, et.al Bioanalytical Method Validation-A

Revisit with a Decade of Progress. Pharmaceutical Research. 2000: 17: 1551 – 1557.

13.11 Shaik Mastan, Thirunagari Bhavya Latha, Sathe Ajay- The basic regulatory considerations and

prospects for conducting bioavailability/bioequiva lence (BA/BE) studies–an overview Comparative

Effectiveness Research 2011:1: 1-25.

13.12 Shah, V.P. The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance

Document on Bioanalytical Methods Validation The AAPS Journal 2007:9(1), E43 - E47.

13.13 Yacobi, T.L., Viswanathan, C.T., Cook, C.E., Mc Dowall, R.D., Pittman, K.A. y Spector, S.

Pharmaceutical research, 1992; 9:588-592.

13.14 Brescolle, F., Bromet-Petrit, M. y Audran, M. Validation of liquid chromatographic and gas

chromatographic methods. Applications to pharmacokinetics Journal of Chromatography B., 1996; 686: 3-10.

13.15 Braggio, S., Grossi, R.J. y Cugola, M. A strategy for validation of bioanalyt ical methods. Journal of

Pharmaceutical and Biomedical Analysis, 1996; 14: 375-388.

13.16 Causon, R. J Validation of chromatographic methods in biomedical analysis. Viewpoint and

discussion. Journal of Chromatography B., 1997; 689: 175-180.

13.17 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish

interchangeability. In: Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical

Preparations. Geneva, World Health Organization. WHO Technical Report Series, No. 937, 2006, Annex 7.

13.18 Interchangeable multi-source pharmaceutical products. WHO draft guideline on marketing

authorization requirements. December 1993.

13.19 Hauck, W.W., Anderson, S. A new statistical pr ocedures for testing equivalence in two-group

comparative bioavailability trials. J. Pharmacokin. Biopharm, 1984; 12:83-91.

13.20 Sokal, R. R., Rohlf, F.J. Biometry: The principles a nd practice of statistics in biological research. 4th

ed. New York: W.H. Freeman and Co., 2011.

13.21 FDA, Guidance. Statistical Approaches to Establishing Bioequivalence. Jan 2011.

13.22 Schuirman, D. J. A comparison of the two one- sided tests procedure and the power approach for

assessing the equivalence of average bioavailability. J. Pharmacokin. Biopharm, 1987; 715:657-680.Pj.

13.23 Westlake, W. J. Response to Kikwood, TBL.: bioe quivalence testing-a need to rethink. Biometrics

1981;37:589-594.

13.24 Schuirmann, D.J. Treatment of bioequivalence data: log transform ation. In: Proceedings of Bio-

International '89 issues in the evaluation of bioavailability data, Toronto, Canada, October 1-4, 1989; 159-161.

13.25 Westlake, W. J. The design and analysis of compar ative blood-level trial. In: Swarbick J. Ed. Current

concepts in the pharmaceutical sciences, dosage form design and bioavailability, Philadelphia: Lea and

Febiger, 1973; 149-179.

13.26 Westlake, W. J. Bioavailability and bioequivalence of pharmaceutical formulations. In. Peace KE. Ed.

Biopharmaceutical statistics for drug development. New York: Marcel Dekker, Inc., 1988; 329-352.

13.27 Locke, C. S. An exact, confidence interval from untransformed data for the ratio of two formulation

means. J. Pharmacokin. Biopharm, 1984; 12:649-655.

13.28 Lund, R. E. Tables for an approxim ate test for outliers in linear models. Technometrics. 1975, 17:

473-476.

13.29 Chow, S. C. & Liu, J. P. Design and Analysis of Bioavailability and Bioequivalence Studies.

Chapman and Hall/CRC; 3a. edition., 2008

13.30 ICH E3 Harmonised Tripartite Guideline Structure and Content of Clinical Study Reports.

13.31 ICH E6 (R1) Good Clinical Practice: Consolidated Guidance.

13.32 ICH E8 Harmonised Tripartite Guideline General Considerations for Clinical Trials.

13.33 ICH E9 Harmonised Tripartite Guideline Statistical Principles for Clinical Trials.

13.34 Norma técnica No. 313. Para la presentación de proyectos e informes técnicos de investigación en

las Instituciones de Salud.

13.35 Norma técnica No. 314. Para el registro y seguimiento en materia de investigación para la Salud.

13.36 Norma técnica No. 315. Para el funcionamiento de Comisiones de investigación en las Instituciones

de atención a la Salud.

13.37 Colegio Nacional de Químicos Farmacéuticos Biólogos México A.C. Guía de validación de métodos

analíticos. 2002.

13.38 European Medicines Agency. Science Medicines Health. Guideline on the investigation of

bioequivalence. 20 Jan 2010.

13.39 Health Canada. Guidance Document. Conduct and A nalysis of Comparative Bioavailability Studies.

08 Feb 2012.

13.41 European Medicines Agency. Science Medicines Health. Guideline on bioanalytical method

validation. 21 Jul 2011.

13.42 Agencia Nacional de Vigilancia Sanitaria. Resolucao DRC No. 27 Dispoe sobre os requisitos

mínimos para a validacao de métodos bioanalíticos em pregnados em estudos com fns de registro e pós-

registro de medicamentos. 27 Maio 2012.

13.43 Acuerdo por el que se emiten las Disposiciones Ge nerales para la Integración y Funcionamiento de

los Comités de Ética en Investigación y se establecen la s unidades hospitalarias que deben contar con ellos,

de conformidad con los criterios establecidos por la Comisión Nacional de Bioética.