In Search of Biomarkers for Drug‐Induced Vascular Injury

Turk, James R.

doi:10.1002/9780470918562.ch11

Cited by 1 publication

(2 citation statements)

References 191 publications

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“…These have included circulating proteins, and even genomic markers, but their utility has been limited by their potential qualification with only a very limited number of compounds, most of which are vasoactive molecules (Brott et al 2005;, Daguès, Pawlowski, Guigon, G, et al 2007Dalmas et al 2008Dalmas et al , 2011Enerson et al 2006;Joseph, Rees, and Dayan 1996;W. Kerns et al 2005; C. Louden et al 2006;Newsholme et al 2000;Stagliano et al 2001;Thomas et al 2009;Thomas et al 2012;Turk 2010;Weaver et al 2008;Zhang et al, 2002b;Zhang et al 2006;2012). The majority of candidate biomarkers have included factors involved in EC activation , edema, inflammation, tissue remodeling, (Blake, and Ridker 2001;Dalmas et al 2008;Daguès, Pawlowski, Guigon, et al 2007;) and maintenance of vascular tone (C. Louden et al 2006).…”

Section: Biomarkers Of Biotherapeutic-associated Divimentioning

confidence: 99%

“…Kerns et al 2005;C. Louden et al 2006;Newsholme et al 2000;Stagliano et al 2001;Thomas et al 2009;Thomas et al 2012;Turk 2010;Weaver et al 2008;Zhang et al, 2002b;Zhang et al 2006;2012). The majority of candidate biomarkers have included factors involved in EC activation (Zhang et al 2010), edema, inflammation, tissue remodeling, (Blake, and Ridker 2001;Dalmas et al 2008;Daguès, Pawlowski, Guigon, et al 2007;) and maintenance of vascular tone (C. Louden et al 2006).…”

Section: Biomarkers Of Biotherapeutic-associated Divimentioning

confidence: 99%

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Scientific and Regulatory Policy Committee Points-to-consider Paper*

Frazier

Engelhardt

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et al. 2015

Toxicol Pathol

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Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. Although DIVI in laboratory animal species has been well characterized for vasoactive small molecules, there is little available information regarding DIVI associated with biotherapeutics such as peptides/proteins or antibodies. Because of the uncertainty about whether DIVI in preclinical studies is predictive of effects in humans and the lack of robust biomarkers of DIVI, preclinical DIVI findings can cause considerable delays in or even halt development of promising new drugs. This review discusses standard terminology, characteristics, and mechanisms of DIVI associated with biotherapeutics. Guidance and points to consider for the toxicologist and pathologist facing preclinical cases of biotherapeutic-related DIVI are outlined, and examples of regulatory feedback for each of the mechanistic types of DIVI are included to provide insight into risk assessment.

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