Module 5 Presentations

05/07/2024

France clinical trial - BIA 10-2474 (7)

• Trial tested doses up to 80 times more (100 mg BIA 10-2474) than should have been required. • Although the protocol summary reports no animal deaths during the studies, the ANSM expert committee reported that in fact several monkeys died or had to be euthanised during the dose escalation studies and that an explanation from Bial was pending. • Also, two animals had to be euthanised in the 13-week dog study due to lung lesions - both from the top dose group.

Biotrial stated its position that "The trial was conducted in full compliance with the international regulations and Biotrial’s procedures, in particular the emergency procedures".

The Organisation for Professionals in Regulatory Affairs

BIA 10-2474

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The Organisation for Professionals in Regulatory Affairs

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