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How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum

PURPOSE: A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator’s Brochure (IB) for meaningful risk assessment of early clinical trials. MATERIALS AND METHODS: Four topics were specifically discu...

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Publicat a:Ther Innov Regul Sci
Autors principals: Rengelshausen, Jens, Breithaupt-Groegler, Kerstin, Donath, Frank, Erb-Zohar, Katharina, Hardman, Tim, Mikus, Gerd, Plassmann, Stephanie, Wensing, Georg, Sourgens, Hildegard
Format: Artigo
Idioma:Inglês
Publicat: Springer International Publishing 2021
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC7857342/
https://ncbi.nlm.nih.gov/pubmed/33537954
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-021-00257-0
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