Browsing by Author "Molins Lleonart, Eduard"
Now showing items 1-5 of 5
-
An iterative method to protect the type I error rate in bioequivalence studies under two-stage adaptive 2×2 crossover designs
Molins Lleonart, Eduard; Labes, Detlew; Schütz, Helmut; Cobo Valeri, Erik; Ocaña Rebull, Jordi (2021-01)
Article
Open AccessBioequivalence studies are the pivotal clinical trials submitted to regulatory agen- cies to support the marketing applications of generic drug products. Average bioequivalence (ABE) is used to determine whether the mean ... -
Long-term costs of colorectal cancer treatment in Spain
Corral, julieta; Castells, Xavier; Molins Lleonart, Eduard; Chiarello, Pietro; Borras Andres, Jose Maria; Cots, Francesc (2016-02-16)
Article
Open AccessBackground: Assessing the long-term cost of colorectal cancer (CRC) increases our understanding of the disease burden. The aim of this paper is to estimate the long-term costs of CRC care by stage at diagnosis and phase ... -
Precisió i variabilitat en la interpretació de la mamografia de cribatge : VILMA
Molins Lleonart, Eduard; Moreno Mallén, María Pilar (Universitat Politècnica de Catalunya, 2005-11)
Master thesis (pre-Bologna period)
Open AccessA Catalunya ens trobem en ple procés d'implantació de programes poblacionals de cribratge de càncer de mama, procés que comporta -i comportarà-una necessitat més gran de radiòlegs per a la lectura i interpretació de les ... -
Proposing some innovative study design features to regulatory agencies (EMA and FDA) in bioequivalence trials : Reference Scaled Average Bioequivalence, and Two-Stage Adaptive Designs
Molins Lleonart, Eduard (Universitat Politècnica de Catalunya, 2021-05-28)
Doctoral thesis
Open AccessIn applications for generic medicinal products the concept of bioequivalence is fundamental. Two medicinal products, i.e. a test and a reference drugs containing the same active substance are considered bioequivalent if ... -
Two-stage designs versus European scaled average designs in bioequivalence studies for highly variable drugs: which to choose?
Molins Lleonart, Eduard; Cobo Valeri, Erik; Ocaña Rebull, Jordi (2017-12)
Article
Open AccessThe usual approach to determine bioequivalence for highly variable drugs is scaled average bioequivalence, which is based on expanding the limits as a function of the within-subject variability in the reference formulation. ...