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Bioequivalencia escalada basada en límites suaves y remuestreo

Authors: Muñoz Gutierrez, Joel Alejandro;

Bioequivalencia escalada basada en límites suaves y remuestreo

Abstract

La agencia europea del medicamento, EMA, y la estadounidense FDA, propusieron límites de bioequivalencia (BE) "escalada" para facilitar la declaración de BE de genéricos de drogas de alta variabilidad (HVD). La EMA, en el 2010 publicó una directriz, donde recomienda actualmente que la bioequivalencia para (HVD) pueda evaluarse utilizando un rango más amplio de aceptación para el intervalo de Cmax. Teniendo en cuenta estos resultados, algunos autores proponen suavizar los límites lineales de la EMA, sin embargo, no se tiene claro cómo realizar la inferencia de BE. En esta memoria proponemos hacer la inferencia mediante técnicas de remuestreo. Dichas técnicas se basan en la metodología bootstrap, tanto paramétrico como no paramétrico. Este nuevo enfoque corrige bastante bien el error de tipo I.

Country
Spain
Keywords

BE escalada, Classificació AMS::62 Statistics::62K Design of experiments, :62 Statistics::62K Design of experiments [Classificació AMS], :Matemàtiques i estadística::Estadística matemàtica [Àrees temàtiques de la UPC], Àrees temàtiques de la UPC::Matemàtiques i estadística::Estadística matemàtica, Remuestreo, Limites suaves, Experimental design, Disseny d'experiments

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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