Safety Analysis Planning for Treatments Used in Multiple Indications
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*Achim Guettner, Novartis Pharma AG 


In this presentation I will give an overview of the planning activities for safety analyses for a compound that is currently in phases II and III in clinical development. The compound is used in multiple indications and therapeutic areas. Doses, regimens and route of administrations differ for the individual populations. For prospectively planning of safety analyses it is important to understand where a common approach across indication can be applied and to understand that the risks might be different across indications. It will be outlined how standard approaches improve the understanding of the safety profile of the drug throughout the development program.