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Drug Discov Today. 2015 Sep;20(9):1135-42. doi: 10.1016/j.drudis.2015.05.010. Epub 2015 May 27.

Integrated risk assessment of suicidal ideation and behavior in drug development.

Author information

1
Global Pharma Development Strategy, Novartis Pharmaceuticals, Switzerland.
2
Head of Toxicology, Genentech, United States.
3
Discovery Toxicology, Bristol-Myers Squibb, United States.
4
Preclinical Safety, Novartis Institutes for Biomedical Research, Switzerland.
5
Safety Pharmacology COE, Pfizer, United States.
6
Preclinical Safety Profiling, Novartis Institutes for Biomedical Research, United States. Electronic address: laszlo.urban@novartis.com.

Abstract

Treatment-related suicidal ideation and behavior (SIB) adverse events are under increasing public, legal and regulatory scrutiny. Prospective assessment of SIB is emerging as a challenging safety requirement by health authorities for the development of drugs but the underlying risk factors remain ill defined. To help with the understanding of risk factors that trigger a prospective assessment of SIB in clinical trials, we present an industry 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 or indication classes associated with high incidence of SIB, in vitro neuropharmacological activity profile, in vivo ADME properties, patient population of the underlying indication and regulatory precedents.

PMID:
26022402
DOI:
10.1016/j.drudis.2015.05.010
[Indexed for MEDLINE]

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