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Integrated Risk Assessment of Suicidal Ideation and Behavior in Drug Development

Mueller, Patrick and Calligaro, David and Dambach, Donna and Gemzik, Brian and Hartmann, Andreas and Ratcliffe, Sian and Trendelenburg, Christian and Urban, Laszlo (2015) Integrated Risk Assessment of Suicidal Ideation and Behavior in Drug Development. Drug Discovery Today, 20 (9). pp. 1135-1142. ISSN 13596446

Abstract

Suicide is a major public health concern with emerging understanding of its neuropharmacological basis. Treatment-related suicidal ideation and behavior (SIB) as adverse events of psychiatric and non-psychiatric drugs are under increasing public, legal and regulatory scrutiny. Prospective assessment of SIB is emerging as a challenging safety requirement by health authorities worldwide for the development of certain drugs while the underlying risk factors remain ill defined. To help with the understanding and harmoniation of risk factors that trigger a prospective assessment of SIB in clinical trials, Bristol-Meyers-Squibb, Eli Lilly, Novartis, Pfizer and Roche/Genentech present a consensus framework for risk assessment and decision making of SIB during drug development. Application of this strategy is based on chemical and pharmacological similarities of compounds with clinical evidence of suicidal intent, target/indication classes associated with high incidence of SIB, in vitro neuropharmacological activity profile, in vivo ADME properties, the patient population of the underlying indication and regulatory precedents.

Item Type: Article
Date Deposited: 26 Apr 2016 23:45
Last Modified: 04 Jul 2016 23:45
URI: https://oak.novartis.com/id/eprint/23321

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