[Clinical drug investigations. Definition of terms].

Autor: Johne A; Institut für Klinische Pharmakologie, Universitätsmedizin, Berlin. andreas.johne@charite.de, Gerloff T, Mai I
Jazyk: němčina
Zdroj: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz [Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz] 2005 Apr; Vol. 48 (4), pp. 397-400.
DOI: 10.1007/s00103-005-1012-y
Abstrakt: Implementation of the European Directive 2001/20/EC led to the inclusion of definitions for clinical trial and non-interventional trial in German Drug Law. Other terms, such as non-commercial clinical trial, single patient use, post marketing surveillance and public health study are less well defined. This article explains the various terms by comparing their differences and similarities.
Databáze: MEDLINE