Numeral 12 — NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de medicamentos, publicada el 3 de agosto de 1996).

12 Bibliografía

12.1 Ley General de Salud.

12.2 Ley Federal sobre Metrología y Normalización.

12.3 Reglamento de Insumos para la Salud.

12.4 Reglamento de la Ley Federal sobre Metrología y Normalización.

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

12.6 Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry:

Stability Testing of Drug Substances and Drug Products (Draft, June 1998).

12.7 European Medicines Agency, Committee for medicinal products for human use & Committee for

medicinal products for veterinary use. Guideline on quality of herbal medicinal products/traditional herbal

medicinal products, 2006.

12.8 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug

Substances and Products (Feb. 2003).

12.9 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1C: Stability Testing for New Dosage

Forms (Nov. 1996).

12.10 Health Canada. Guidance for Industry: Stability Testing of Existing Drug Substances and Products,

2003.

12.11 Health Canada. Guidance for Industry: Identification, Qualification, and Control of related impurities

in Existing Drugs (April 1999, Draft No. 4).

12.12 International Confer ence on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline 5C: Quality of Biotechnological

Products: Stability Testing of Biotechnological/Biological Products.

12.13 Scale-up and P ost-Approval Changes (SUPAC) Guidance, Immediate Release Solid Oral Dosage

Forms: Chemistry, Manufacturing and Controls, In Vitro 1 Dissolution Testing, and In Vivo Bioequivalence

Documentation.

12.14 Drug Stability: Principles and Practices, Carstensen and Rhodes, Third Edition, USA 2000.

12.15 International Pharmaceutical Product Registration: Stability Data, Cartwright & Matthews, USA 1995.

12.16 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for H uman Use, ICH Harmonised Tripartite Guideline Q3A(R): Impurities in New Drug

Substances (Feb. 2002).

12.17 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guid eline Q3B(R): Impurities in New Drug

Products (Feb. 2003).

12.18 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3C: Impurities Residual Solvents

(Dec. 1997).

12.19 Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry.

12.19.1 ANDAs: Impurities in Drug Products (Dec. 1998).

12.19.2 ANDAs: Impurities in Drug Substances (Nov. 1999).

12.20 Chemical Stability of Pha rmaceuticals: A Handbook for Pharmacists, 2nd Edition, Connors K. A.,

Amidon G. L. and Stella V. J., J. Wiley and Sons, USA (1986).

12.21 World Health Organization. Guidelines on stability evaluation of vaccines Annex_3_WHO_TRS_962-3.

12.22 World Health Organization. Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability

testing of active pharmaceutical ingredients and finished pharmaceutical products.

12.23 WHO Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability tes ting of active

pharmaceutical ingredientes and finished pharmaceutical products, que se ha incluido en la bibliografía de la

norma. La misma OMS emitió una tabla de las condiciones de temperatura y humedad por país (table 2,

stability conditions for WHO Member States by Region)