Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Autor: Machado FLDS; Instituto de Ciências Farmacêuticas, Universidade Federal do Rio de Janeiro, Macaé, Rio de Janeiro, Brazil; Sorocaba University, Sorocaba, São Paulo, Brazil., Cañás M; Universidad Nacional Arturo Jauretche-FEMEBA, La Plata, Argentina., Doubova SV; Epidemiology and Health Services Research Unit, Mexican Institute of Social Security, Mexico City, Mexico., Urtasun MA; Universidad Nacional Arturo Jauretche-FEMEBA, La Plata, Argentina., Marín GH; Universidad Nacional de La Plata-CONICET, La Plata, Argentina., Osorio-de-Castro CGS; National School of Public Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil., Albuquerque FC; Ministry of Health, Brasília, Distrito Federal, Brazil., Ribeiro TB; Post Graduate Program in Epidemiology, Department of Epidemiology, School of Public Health, University of São Paulo, São Paulo, Brazil., Pont L; University of Technology Sydney, Sydney, Australia., Crisóstomo Landeros J; Instituto de Salud Pública de Chile, Santiago, Chile., Roldán Saelzer J; Instituto de Salud Pública de Chile, Santiago, Chile., Sepúlveda Viveros D; Universidad Autónoma de Chile and Universidad del Desarrollo, Santiago, Chile., Acosta A; Facultad de Ciencias Naturales, Departamento de Ciencias Farmacéuticas, Universidad ICESI, Cali, Colombia., Machado Beltrán MA; Universidad Nacional de Colombia, Bogotá, Colombia., Gordillo Alas LI; Department of Regulation and Control of Pharmaceutical and Related Products, Ministry of Public Health and Social Assistance, Guatemala City, Guatemala., Orellana Tablas LA; Department of Regulation and Control of Pharmaceutical and Related Products, Ministry of Public Health and Social Assistance, Guatemala City, Guatemala., Benko R; Institute of Clinical Pharmacy, University of Szeged, Szeged, Hungary., Convertino I; University of Pisa, Pisa, Italy., Bonaso M; University of Pisa, Pisa, Italy., Tuccori M; University of Pisa, Pisa, Italy., Kirchmayer U; Department of Epidemiology, Lazio Regional Health Service, Rome, Italy., Contreras Sánchez SE; Epidemiology and Health Services Research Unit, Mexican Institute of Social Security, Mexico City, Mexico., Rodríguez-Tanta LY; Carrera de Farmacia y Bioquímica, Facultad de Ciencias de la Salud, Universidad Científica del Sur, Lima, Perú., Gutierrez Aures Y; Ministry of Health of Peru, Lima, Peru., Lin B; University of Florida, United States., Alipour-Haris G; University of Florida, United States., Eworuke E; Epidemiology and Drug Safety Team, Real World Solutions, IQVIA, United States., Lopes LC; Sorocaba University, Sorocaba, São Paulo, Brazil. Electronic address: luciane.lopes@prof.uniso.br.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Oct; Vol. 144, pp. 105485. Date of Electronic Publication: 2023 Sep 01.

Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

Autor: Machado FLDS; Federal University of Rio de Janeiro, UFRJ, Macaé, Brazil., Dos Santos DMSS; Federal University of Rio de Janeiro, UFRJ, Macaé, Brazil., Lopes LC; Pharmaceutical Sciences Graduate Course, University of Sorocaba, UNISO, Sorocaba, Brazil.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2021 Apr 22; Vol. 12, pp. 612426. Date of Electronic Publication: 2021 Apr 22 (Print Publication: 2021).