Tags

Type your tag names separated by a space and hit enter

[Clinical drug investigations. Definition of terms].

Abstract

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.

Authors+Show Affiliations

Institut für Klinische Pharmakologie, Universitätsmedizin, Berlin. andreas.johne@charite.deNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article

Language

ger

PubMed ID

15830249

Citation

Johne, A, et al. "[Clinical Drug Investigations. Definition of Terms]." Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, vol. 48, no. 4, 2005, pp. 397-400.
Johne A, Gerloff T, Mai I. [Clinical drug investigations. Definition of terms]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005;48(4):397-400.
Johne, A., Gerloff, T., & Mai, I. (2005). [Clinical drug investigations. Definition of terms]. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 48(4), 397-400.
Johne A, Gerloff T, Mai I. [Clinical Drug Investigations. Definition of Terms]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005;48(4):397-400. PubMed PMID: 15830249.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Clinical drug investigations. Definition of terms]. AU - Johne,A, AU - Gerloff,T, AU - Mai,I, PY - 2005/4/15/pubmed PY - 2005/11/11/medline PY - 2005/4/15/entrez SP - 397 EP - 400 JF - Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz JO - Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz VL - 48 IS - 4 N2 - 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. SN - 1436-9990 UR - https://www.unboundmedicine.com/medline/citation/15830249/[Clinical_drug_investigations__Definition_of_terms]_ L2 - https://dx.doi.org/10.1007/s00103-005-1012-y DB - PRIME DP - Unbound Medicine ER -