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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Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: Rengelshausen, Jens, Breithaupt-Groegler, Kerstin, Donath, Frank, Erb-Zohar, Katharina, Hardman, Tim, Mikus, Gerd, Plassmann, Stephanie, Wensing, Georg, Sourgens, Hildegard
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2021
Assuntos:
Original Research
Acesso em linha: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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