Who is a ‘healthy subject’?—consensus results on pivotal eligibility criteria for clinical trials

INTRODUCTION/METHODS: A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry,...

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Detalles Bibliográficos
Autores principales: Breithaupt-Groegler, Kerstin, Coch, Christoph, Coenen, Martin, Donath, Frank, Erb-Zohar, Katharina, Francke, Klaus, Goehler, Karin, Iovino, Mario, Kammerer, Klaus Peter, Mikus, Gerd, Rengelshausen, Jens, Sourgens, Hildegard, Schinzel, Reinhard, Sudhop, Thomas, Wensing, Georg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2017
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350217/
https://www.ncbi.nlm.nih.gov/pubmed/28064353
http://dx.doi.org/10.1007/s00228-016-2189-8

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