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Comment
. 2014 Mar;16(2):350-1.
doi: 10.1208/s12248-014-9570-2. Epub 2014 Feb 4.

Similarities and differences of international guidelines for bioequivalence: an update of the Brazilian requirements

Camila Fracalossi Rediguieri  1 , Rodrigo Cristofoletti, Kelen Carine Costa Soares, João Tavares-Neto
Affiliations
Comment

Similarities and differences of international guidelines for bioequivalence: an update of the Brazilian requirements

Camila Fracalossi Rediguieri et al. AAPS J. 2014 Mar.
No abstract available

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References

    1. Davit B, Braddy AC, Conner DP, Yu LX. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J. 2013;15(4):974–990. doi: 10.1208/s12248-013-9499-x. - DOI - PMC - PubMed
    1. Guideline for relative bioavailability/bioequivalence tests of medicines—RE n.1170/2006. Brazilian Health Surveillance Agency (ANVISA) 2006. http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagi.... Accessed 5 Nov 2013.
    1. Guideline for pilot batch notification—IN n.02/2009. Brazilian Health Surveillance Agency (ANVISA) 2009. http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagi.... Accessed 5 Nov 2013.
    1. Guideline for biowaiver and relative bioavailability/bioequivalence study substitution—RDC n.37/2011. Brazilian Health Surveillance Agency (ANVISA) 2011. http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=1&pagi.... Accessed 5 Nov 2013.
    1. Medication administration condition. Brazilian Health Surveillance Agency (ANVISA) 2013. http://portal.anvisa.gov.br/wps/wcm/connect/2216ec00408e800c9d3edff7d85a.... Accessed 5 Nov 2013.

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