Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?

Pharmaceutical equivalence is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. The aim of this paper is to compare traditional difference testing to two one-side equ...

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Autores principales: Lourenço, Felipe R., Pinto, Terezinha J. A.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2012
Materias:
Farmacia
evaluación de conocimientos
Difference test
Equivalence test
Pharmaceutical equivalence
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/20189
http://www.latamjpharm.org/resumenes/31/4/LAJOP_31_4_1_16.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-20189
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
evaluación de conocimientos
Difference test
Equivalence test
Pharmaceutical equivalence
spellingShingle Farmacia
evaluación de conocimientos
Difference test
Equivalence test
Pharmaceutical equivalence
Lourenço, Felipe R.
Pinto, Terezinha J. A.
Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
topic_facet Farmacia
evaluación de conocimientos
Difference test
Equivalence test
Pharmaceutical equivalence
description Pharmaceutical equivalence is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. The aim of this paper is to compare traditional difference testing to two one-side equivalence tests in the assessment of pharmaceutical equivalence, by means of equivalence studies between similar, generic and reference products of acyclovir cream, atropine sulfate injection, meropenem for injection, and metronidazole injection. All tests were performed in accordance with the Brazilian Pharmacopeia or the United States Pharmacopeia. All four possible combinations of results arise in these comparisons of difference testing and equivalence testing. Most of the former did not show significant difference, whereas the latter presented similarity. We concluded that equivalence testing is more appropriate than difference testing, what can make it a useful tool to assess pharmaceutical equivalence in products that will not be tested for bioequivalence.
format Articulo
Articulo
author Lourenço, Felipe R.
Pinto, Terezinha J. A.
author_facet Lourenço, Felipe R.
Pinto, Terezinha J. A.
author_sort Lourenço, Felipe R.
title Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
title_short Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
title_full Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
title_fullStr Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
title_full_unstemmed Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
title_sort assessment of pharmaceutical equivalence: difference test or equivalence test?
publishDate 2012
url http://sedici.unlp.edu.ar/handle/10915/20189
http://www.latamjpharm.org/resumenes/31/4/LAJOP_31_4_1_16.pdf
work_keys_str_mv AT lourencofeliper assessmentofpharmaceuticalequivalencedifferencetestorequivalencetest
AT pintoterezinhaja assessmentofpharmaceuticalequivalencedifferencetestorequivalencetest
bdutipo_str Repositorios
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