This article aims to explore the regulatory and medicolegal aspects of experimental drug trials. Firstly, the authors provide definitions of drug according to WHO, the European Community and our official Pharmacopoeia, and that of experimental studies. They then explain the distinction between pure or basic research and drug trials and explain the various phases of the latter. Besides providing definitions, and exploring doctrinal, theoretical but also practical aspects of drug trials, the authors also discuss and analyze legislative aspects, with particular reference to the Italian legislative framework, and medicolegal issues, including informed consent, effects on humans, and professional responsibility.

Cammarano, A., De Deminicis, E., Marella, G.l., Maurici, M., Arcudi, G. (2016). Aspetti normativi e considerazioni medico-legali sulla sperimentazione farmacologica clinica. IGIENE E SANITÀ PUBBLICA, LXXI(2), 145-156.

Aspetti normativi e considerazioni medico-legali sulla sperimentazione farmacologica clinica

Andrea Cammarano;Gian Luca Marella;Massimo Maurici
;
Giovanni Arcudi
2016-03-01

Abstract

This article aims to explore the regulatory and medicolegal aspects of experimental drug trials. Firstly, the authors provide definitions of drug according to WHO, the European Community and our official Pharmacopoeia, and that of experimental studies. They then explain the distinction between pure or basic research and drug trials and explain the various phases of the latter. Besides providing definitions, and exploring doctrinal, theoretical but also practical aspects of drug trials, the authors also discuss and analyze legislative aspects, with particular reference to the Italian legislative framework, and medicolegal issues, including informed consent, effects on humans, and professional responsibility.
mar-2016
Pubblicato
Rilevanza nazionale
Articolo
Esperti anonimi
Settore MED/43 - MEDICINA LEGALE
Settore MED/42 - IGIENE GENERALE E APPLICATA
Italian
Cammarano, A., De Deminicis, E., Marella, G.l., Maurici, M., Arcudi, G. (2016). Aspetti normativi e considerazioni medico-legali sulla sperimentazione farmacologica clinica. IGIENE E SANITÀ PUBBLICA, LXXI(2), 145-156.
Cammarano, A; De Deminicis, E; Marella, Gl; Maurici, M; Arcudi, G
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/199388
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