REGULATORY CONSIDERATIONS IN THE DEVELOPMENT OF CLINICAL TRIALS

Autores/as

  • Luis Alfredo Ayala Ayala Clinical Trials Unit, Superintendency of Health Regulation Autor/a

Resumen

N/A

Referencias

Conferencia Internacional sobre Armonización de Requisitos Técnicos para el Registro de Productos Farmacéuticos de Uso Humano. (2000). Guía de buenas prácticas de manufactura para ingredientes farmacéuticos activos. ICH Q7. https://database.ich.org/sites/default/files/Q7%20Guideline.pdf

Conferencia Internacional de Armonización de Requisitos Técnicos para el Registro de Productos Farmacéuticos de Uso Humano. (2025).

Guía de buenas prácticas clínicas ICH E6 (R3). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106_ErrorCorrections_2025_1024.pdf

Food and Drug Administration. (1995). Content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including wellcharacterized, therapeutic, biotechnology-derived products: Guidance for industry. U.S. Department of Health and Human Services. https://www.fda.gov/media/71203/download

Food and Drug Administration, Center for Drug Evaluation and Research. (2003). INDs for phase 2 and phase 3 studies: Chemistry, manufacturing, and controls information. U.S. Department of Health and Human Services. https://www.fda.gov/media/70822/download

Friedman, L. M., et al. (2015). Fundamentals of clinical trials. Springer International Publishing. https://doi.org/10.1007/978-3-319-18539-2

International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2009). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals ICH M3(R2). https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf

International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1998). Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing) ICH S4. https://database.ich.org/sites/default/files/S4_Guideline.pdf

Organisation for Economic Co-operation and Development. (1998). OECD principles on good laboratory practice. https://doi.org/10.1787/9789264078536-en

Organización Panamericana de la Salud. (2026). Portal de ensayos clínicos de las Américas—OPS/OMS. https://www.paho.org/es/portalensayosclinicos-americas

Ro, J. (2025). What is CMC in the drug development process? Biotech at Scale. https://www.thermofisher.com/blog/biotechnology/what-iscmc-in-the-drug-development-process/

U.S. Food and Drug Administration. (2005). Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. U.S. Department of Health and Human Services. https://www.fda.gov/media/72309/download

Vera Carrasco, O. (2022). Ensayos o estudios clínicos y sus fases con medicamentos. Revista Médica La Paz, 28(1), 59–63. http://www.scielo.org.bo/pdf/rmcmlp/v28n1/1726-8958-rmcmlp-28-01-59.pdf

WMA - The World Medical Association. (2024). Declaración de Helsinki de la AMM – Principios éticos para las investigaciones médicas en seres humanos. https://www.wma.net/es/policies-post/declaracion-de-helsinki-de-la-amm-principioseticos-para-las-investigaciones-medicas-enseres-humanos/

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Publicado

2026-08-07

Número

Sección

ARTÍCULO DE ENFOQUE REGULATORIO