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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Detalles Bibliográficos
Autores principales: Rengelshausen, Jens, Breithaupt-Groegler, Kerstin, Donath, Frank, Erb-Zohar, Katharina, Hardman, Tim, Mikus, Gerd, Plassmann, Stephanie, Wensing, Georg, Sourgens, Hildegard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7857342/
https://www.ncbi.nlm.nih.gov/pubmed/33537954
http://dx.doi.org/10.1007/s43441-021-00257-0

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