UMH - Clinical trials.

About: Clinical trials.

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Courses:

Know how to explain the basic ideas of translational research in neuropsychopharmacology.
Know and explain the diferent clinical assays.

Introduction (I). Clinical trials for drug development.
Introduction (III). Ethics in human clinical research.
Clinical trial methodology.
Clinical trial. Dessign (I) introduction.
Clinical trial. Dessign (II). Objectives, variables and statistical analysis.
Clinical trial. Design (III). Controls, placebo, sample size.
Clinical trial. Design (IV). Phases of clinical research in humans.
Clinical trial. Bioequivalence studies.
Clinical trial. Legal regulation (I): good clinical practice rules and ICH.
Clinical trial. Legal regulation (II): Ethics committee for clinical research.
Drug clinical research organization. Role of CROs.
Utility for other studies. Observational studies (methodology, dessign, legal regulation and organization).