title: Pharmacogenetics and ethnicity: relevance for clinical implementation, clinical trials, pharmacovigilance and drug regulation in Latin America.
abstract: Congress of Pharmacogenetics and Personalized Medicine. Ethnicity, clinical implementation and regulatory environment (MESTIFAR 2016 Quito) Quito, Ecuador, 19-21 May 2016. The Ibero-American Network of Pharmacogenetics and Pharmacogenomics (RIBEF) was created in 2006 with the main aim of promoting personalized medicine and collaborative pharmacogenetics research in Spanish- and Portuguese-speaking countries in America and the Iberian Peninsula. The final goal of this initiative was the inclusion of Latin American populations that may benefit from the implementation of personalized medicine in drug therapy. Several initiatives have been promoted including the MESTIFAR project, which aimed to analyze the ethnicity, genotype and/or metabolic phenotype in Ibero-American populations. To date, 6060 healthy volunteers have been analyzed; among them, 2571 were admixed, 1824 were Caucasians, 1395 were Native Americans, 174 were Jews and 96 were Afro-descendants. Due to the large genetic variability within Latin Americans, ethnicity may be a relevant factor for the clinical implementation of personalized medicine. Moreover, the present status of clinical implementation and the future perspectives of pharmacogenetics, pharmacovigilance and clinical trials for drug regulation in Latin America compared with the EMA-Pharmacogenomics Working Party and the US FDA initiatives were analyzed.
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Instituto Politéctico Nacional-CIIDIR, Unidad Durango, Academia de Genómica, Durango, Mexico.
authors: Martha
authors: M
authors: Sosa-Macías
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Colegio de Ciencias de la Salud, Universidad San Francisco de Quito, Quito, Ecuador.
authors: Enrique
authors: E
authors: Teran
authors: Comité de Ética en Seres Humanos, Universidad San Francisco de Quito, Quito, Ecuador.
authors: William
authors: W
authors: Waters
authors: Facultad de Medicina, Universidad de las Américas, Quito, Ecuador.
authors: Martha M
authors: MM
authors: Fors
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Universidad Nacional Autónoma de Nicaragua, León, Facultad de Medicina, Nicaragua.
authors: Catalina
authors: C
authors: Altamirano
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Facultad de Química, Universidad Nacional Autónoma de México, México.
authors: Helgi
authors: H
authors: Jung-Cook
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Instituto Politéctico Nacional-CIIDIR, Unidad Durango, Academia de Genómica, Durango, Mexico.
authors: Carlos
authors: C
authors: Galaviz-Hernández
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Departamento de Sistemas Biológicos, Universidad Autónoma Metropolitana, Xochimilco, México.
authors: Marisol
authors: M
authors: López-López
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Centro para el Control Estatal de Medicamentos, La Habana, Cuba.
authors: Diadelis
authors: D
authors: Remírez
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Facultad de Ciencias Médicas, Pontificia Universidad Católica Argentina, Buenos Aires, Argentina.
authors: Graciela E
authors: GE
authors: Moya
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Facultad de Ciencias Médicas, Universidad Estatal de Guayaquil, Guayaquil, Ecuador.
authors: Francisco
authors: F
authors: Hernández
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|CICAB Clinical Research Centre, Extremadura University Hospital & Medical School, Badajoz, Spain.
authors: Humberto
authors: H
authors: Fariñas
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Universidad Nacional Autónoma de Nicaragua, León, Facultad de Medicina, Nicaragua.
authors: Ronald
authors: R
authors: Ramírez
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Genetics Section, Universidad de Costa Rica, San José, Costa Rica.
authors: Carolina
authors: C
authors: Céspedes-Garro
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|Universidade Federal de Minas Gerais, Instituto de Ciencias Biológicas, Departamento de Biologia Geral, Belo Horizonte, Brazil.
authors: Eduardo
authors: E
authors: Tarazona-Santos
authors: RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.|CICAB Clinical Research Centre, Extremadura University Hospital & Medical School, Badajoz, Spain.
authors: Adrián
authors: A
authors: LLerena
keywords: Latin American populations; clinical trials; metabolic genotypes; metabolic phenotypes; native populations; pharmacogenetics; pharmacovigilance