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AGAH manuscript accepted for publication
Today, the AGAH manuscript "How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment – Results of an AGAH Discussion Forum", has been accepted for publication in Therapeutic Innovation & Regulatory Science. Dr. Plassmann co-authored this article which summarises the discussions at the forum 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.
Dr. Lutz Wiesner, BfArM and Dr. Plassmann, PCS presented together on the topic: Potential risks for human subjects associated with inadequate non-clinical safety assessment, to provide guidance from both a Regulator's and a Sponsor's perspective on Dos and Don'ts for adequately written IBs. This joint and further presentations can be downloaded from the AGAH-Website at: