GENDER INFLUENCE IN DRUG BIOEQUIVALENCE STUDIES

Authors

  • José Wellithom Viturino da Silva Departamento de Ciências Farmacêuticas- Universidade Federal de Pernambuco. Av Prof Artur de Sá, s/n, 50740-520, Cidade Universitária, Recife-PE, Brasil.
  • Rafael Ferreira de Lima Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480
  • Ana Rosa Brissant de Andrade Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480
  • Juliana Kishishita Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480
  • Leila Bastos Leal Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480
  • Giovana Damasceno Sousa Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480

DOI:

https://doi.org/10.14450/2318-9312.v29.e1.a2017.pp61-67

Keywords:

Bioequivalence, Methyldopa, Diazepam, Scopolamine Butylbromide

Abstract

Anatomical and physiological differences between the male and female can change the pharmacokinetic process of a drug and thus interfere with its bioavailability, making a particular drug non-bioequivalent when compared in only one gender. The aim of this study was to evaluate the influence of gender on the bioequivalence study of three drug tests in coated tablet form: Methyldopa 500 mg, Diazepam 10 mg and Scopolamine Butylbromide 10 mg. Therefore, the pharmacokinetic parameters that determine the bioequivalence, ASC0-t, ASC0-∞ and Cmax, were recalculated considering the gender separately. The studies of Diazepam and Scopolamine were bioequivalent for both gender but not bioequivalent when considered only women. Methyldopa’s bioequivalence study was not bioequivalent for both sex or for the genders separately. Thus, a more careful evaluation is necessary to analyze and define the bioequivalence of medicines, in order to ensure the efficiency and safety of treatments for both genders.

Author Biography

Giovana Damasceno Sousa, Departamento de Farmácia - Centro Universitário Maurício de Nassau. Rua Joaquim Nabuco, 615, Graças - Recife-PE, Brasil. CEP: 50010-480

Doutora  em Ciências Farmacêuticas pelo Programa de Pós-graduação em Ciências Farmacêuticas da Universidade Federal de Pernambuco (PPGCF/UFPE), pesquisadora do Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC/UFPE) e Gerente da Garantia da Qualidade do Centro de Biodisponibilidade/Bioequivalência (CBIO - NUDFAC/UFPE). Tem experiência em garantia da qualidade, desenvolvimento farmacotécnico de novos produtos, desenvolvimento e validação de métodos analíticos, técnicas de avaliação da permeação cutânea, controle de qualidade e avaliação da estabilidade de produtos farmacêuticos e cosméticos.

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Published

2017-04-03

How to Cite

da Silva, J. W. V., de Lima, R. F., de Andrade, A. R. B., Kishishita, J., Leal, L. B., & Sousa, G. D. (2017). GENDER INFLUENCE IN DRUG BIOEQUIVALENCE STUDIES. Infarma - Pharmaceutical Sciences, 29(1), 61–67. https://doi.org/10.14450/2318-9312.v29.e1.a2017.pp61-67

Issue

Vol. 29 No. 1 (2017)

Section

Original article

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