Journal of Pharmacovigilance

Monroy-Cruz María Teresa

Publications

• Research Article
  Implementation of a Robust Pharmacovigilance Method for Filgrastim Non-Innovator Products in Cancer Patients in Routine Clinical Practice Complying With Mexican Regulations for Biocomparables
  
  Author(s): Huerta-Sanchez Olivid Marisol, Aguilar-Ponce José Luis, Meneses-García Abelardo, Herrera-Gómez Ángel, Herrera-Hernández Ricardo, Monroy-Cruz María Teresa, Burgeño-Ferreira Juan Andrés, Castañeda-Hernández Gilberto and López-Gamboa MireyaHuerta-Sanchez Olivid Marisol, Aguilar-Ponce José Luis, Meneses-García Abelardo, Herrera-Gómez Ángel, Herrera-Hernández Ricardo, Monroy-Cruz María Teresa, Burgeño-Ferreira Juan Andrés, Castañeda-Hernández Gilberto and López-Gamboa Mireya
  
  Background and aim: Mexico, as other countries, has recently changed regulatory requirements for noninnovator biopharmaceuticals (biocomparables); a suitable pharmacovigilance program being now mandatory. Hence, our aim was to implement a robust pharmacovigilance method for filgrastim products of different brands used in routine clinical practice in Mexico. Method: Prospective, phase IV, non-interventional study performed at the Instituto Nacional de Cancerología (National Institute of Cancerology) of Mexico. All pharmacy dispensations of filgrastim products were reviewed and recorded during four months. Patients received a diary for voluntary notation of adverse drug reactions (ADR) every time they were dispensed filgrastim. Additionally, medical records were consulted and contr.. View More»
  DOI: 10.4172/2329-6887.1000174

  Abstract