[Clinical drug investigations. Definition of terms].
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.
Johne
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Institut für Klinische Pharmakologie, Universitätsmedizin, Berlin. andreas.johne@charite.de
Gerloff
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Mai
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D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*