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药物遗传学与种族:对拉丁美洲临床应用、临床试验、药物警戒及药物监管的相关性

Pharmacogenetics and ethnicity: relevance for clinical implementation, clinical trials, pharmacovigilance and drug regulation in Latin America.

作者信息

Sosa-Macías Martha, Teran Enrique, Waters William, Fors Martha M, Altamirano Catalina, Jung-Cook Helgi, Galaviz-Hernández Carlos, López-López Marisol, Remírez Diadelis, Moya Graciela E, Hernández Francisco, Fariñas Humberto, Ramírez Ronald, Céspedes-Garro Carolina, Tarazona-Santos Eduardo, LLerena Adrián

机构信息

RIBEF, Ibero-American Network of Pharmacogenetics & Pharmacogenomics, Mérida, Badajoz, Spain.

Instituto Politéctico Nacional-CIIDIR, Unidad Durango, Academia de Genómica, Durango, Mexico.

出版信息

Pharmacogenomics. 2016 Nov;17(16):1741-1747. doi: 10.2217/pgs-2016-0153. Epub 2016 Oct 28.

DOI:10.2217/pgs-2016-0153
PMID:27790935
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.

摘要

药物基因组学与个性化医学大会。种族、临床应用与监管环境(2016年基多MESTIFAR会议),厄瓜多尔基多,2016年5月19 - 21日。伊比利亚美洲药物基因组学与药物基因组学网络(RIBEF)于2006年成立,其主要目标是在美洲讲西班牙语和葡萄牙语的国家以及伊比利亚半岛推动个性化医学和药物基因组学合作研究。该倡议的最终目标是纳入可能从药物治疗中个性化医学应用中受益的拉丁美洲人群。已经推动了多项举措,包括MESTIFAR项目,该项目旨在分析伊比利亚美洲人群的种族、基因型和/或代谢表型。迄今为止,已对6060名健康志愿者进行了分析;其中,2571人是混血儿,1824人是高加索人,1395人是美洲原住民,174人是犹太人,96人是非洲裔。由于拉丁美洲人内部存在较大的基因变异性,种族可能是个性化医学临床应用的一个相关因素。此外,还分析了与欧洲药品管理局药物基因组学工作组和美国食品药品监督管理局举措相比,拉丁美洲药物基因组学、药物警戒和药物监管临床试验的临床应用现状及未来前景。

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