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Springer Good Clinical Practice I: Grundlagen und Strategie (Konzepte in der Humanpharmakologie)

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Description

Die Humanpharmakologie wendet heute differenziert Modelle zur Absch{tzung der Medikamentenwirksamkeit an, sie liefert Kernaussagen zur Vertr{glichkeit, sie standardisiert und optimiert Untersuchungsmethoden. Dasvorliegende Buch ist dem Schwerpunkt Good Clinical Practice gewidmet. Die dazu k}rzlich fertiggestellten europ{ischen Richtlinien bieten sich durch die Vorgabe einheitlicher Kriterien als Richtschnur f}r alle klinischen Pr}fungen an. Folgende Aspekte werden behandelt: Planung von Studien, Kriterien f}r Good Clinical Practice, rechtliche und ethische Fragen, Probanden, Verarbeitung der gewonnenen Informationen. F}r Mitarbeiter in der Arzneimittelforschung liefert das Buch eine hochaktuelle Diskussions- und Arbeitsgrundlage.

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