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Fundamentals of Clinical Research: Bridging Medicine, Statistics and Operations

Antonella Bacchieri Giovanni Della Cioppa

Resumen/Descripción – provisto por la editorial

No disponible.

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Institución detectada Año de publicación Navegá Descargá Solicitá
No detectada 2007 SpringerLink

Información

Tipo de recurso:

libros

ISBN impreso

978-88-470-0491-7

ISBN electrónico

978-88-470-0492-4

Editor responsable

Springer Nature

País de edición

Reino Unido

Fecha de publicación

Información sobre derechos de publicación

© Springer-Verlag Italia, Milano 2007

Tabla de contenidos

Study Variants Applicable to More than One Type of Design: Equivalence Studies, Interim Analyses, Adaptive Plans and Repeated Measurements

In this chapter we will cover study variants that can be applied both to designs based on between-subject comparisons and to those based on within-subject comparisons.

Palabras clave: Experimental Treatment; Interim Analysis; Equivalence Study; Sequential Design; Reference Treatment.

Pp. 277-303

The Drug Development Process and the Phases of Clinical Research

The reader should be aware of two semantic conventions we adopted in this chapter: first, the terms “research” and “development” are used interchangeably; second, the term “drug”, which technically only applies to compounds with proven efficacy and effectiveness, is also used to indicate compounds undergoing the development process, for which, by definition, efficacy and effectiveness have not be proven.

Palabras clave: Clinical Development; Maximum Tolerate Dose; Therapeutic Area; Pivotal Study; Preclinical Development.

Pp. 304-328