(Q38365744)

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Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics

scientific article published on 26 February 2015

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Europe PubMed Central

PubMed publication ID

2 September 2017

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Europe PubMed Central

Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics (English)

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

author name string

Kendall S Frazier

1

1 reference

Europe PubMed Central

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2 September 2017

Jeffery A Engelhardt

2

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Pierluigi Fant

3

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Silvia Guionaud

4

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Scott P Henry

5

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Michael W Leach

6

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Calvert Louden

7

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Marshall S Scicchitano

8

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

James L Weaver

9

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Tanja S Zabka

10

1 reference

Europe PubMed Central

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2 September 2017

Society of Toxicologic Pathology Vascular Injury Working Group

11

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Europe PubMed Central

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2 September 2017

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publication date

26 February 2015

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Europe PubMed Central

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2 September 2017

Toxicologic Pathology

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Europe PubMed Central

PubMed publication ID

2 September 2017

43

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Europe PubMed Central

PubMed publication ID

2 September 2017

7

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

915-934

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

Coronary arteriopathy in monkeys following administration of CI-1020, an endothelin A receptor antagonist.

1 reference

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Studies on coronary arteriopathy in dogs following administration of CI-1020, an endothelin A receptor antagonist.

1 reference

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21 January 2018

The role of microparticles in inflammation and thrombosis

1 reference

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21 January 2018

Endothelium-derived nitric oxide and vascular physiology and pathology

1 reference

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21 January 2018

Protective genes expressed in endothelial cells: a regulatory response to injury

1 reference

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21 January 2018

Translation strategy for the qualification of drug-induced vascular injury biomarkers.

1 reference

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21 January 2018

Biomarkers of inflammation and endothelial function: the holy grail of experimental and clinical medicine?

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21 January 2018

Novel clinical markers of vascular wall inflammation

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21 January 2018

Circulating endothelial cells, arterial stiffness, and cardiovascular risk stratification in hypertension

1 reference

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21 January 2018

Endothelial cells are a target of both complement and kinin system.

1 reference

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21 January 2018

Cross-talk between the complement and the kinin system in vascular permeability

1 reference

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21 January 2018

Immunogenicity of therapeutic proteins: the use of animal models

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21 January 2018

Endothelial and platelet microparticles in vasculitis of the young.

1 reference

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21 January 2018

Biomarkers of drug-induced vascular injury.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Spontaneous lesions of the cardiovascular system in purpose-bred laboratory nonhuman primates.

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21 January 2018

ANCA-associated vasculitides--advances in pathogenesis and treatment

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21 January 2018

Mechanisms of adverse drug reactions to biologics

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21 January 2018

Differentiating spontaneous from drug-induced vascular injury in the dog.

1 reference

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21 January 2018

Subchronic toxicity of orally administered (gavage and dosed-feed) theophylline in Fischer 344 rats and B6C3F1 mice

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21 January 2018

Circulating markers of endothelial function in cardiovascular disease

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Animal models of anti-neutrophil cytoplasmic antibody-associated vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Altered gene expression in rat mesenteric tissue following in vivo exposure to a phosphodiesterase 4 inhibitor.

1 reference

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21 January 2018

Distinct endothelial phenotypes evoked by arterial waveforms derived from atherosclerosis-susceptible and -resistant regions of human vasculature.

1 reference

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21 January 2018

Transcriptional profiling of laser capture microdissected rat arterial elements: fenoldopam-induced vascular toxicity as a model system

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21 January 2018

Potential candidate genomic biomarkers of drug induced vascular injury in the rat.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Where disease pathogenesis meets protein formulation: renal deposition of immunoglobulin aggregates.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

The many faces of endothelial microparticles.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Drug-induced vasculitides

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Acute drug-induced vascular injury in beagle dogs: pathology and correlating genomic expression

1 reference

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21 January 2018

Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Diagnostic role of endothelial microparticles in vasculitis.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Anti-neutrophil cytoplasmic autoantibodies induce neutrophils to degranulate and produce oxygen radicals in vitro

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

The spectrum of vasculitis: clinical, pathologic, immunologic and therapeutic considerations

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Diffuse endothelial dysfunction is common to ANCA associated systemic vasculitis and polyarteritis nodosa

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Physiology of the endothelium

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Review article: Drug-induced anti-neutrophil cytoplasmic antibody-associated vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Vascular trauma induces rapid but transient mobilization of VEGFR2(+)AC133(+) endothelial precursor cells

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21 January 2018

Vasodilator signals from perivascular adipose tissue

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21 January 2018

Toxicity as a result of immunostimulation by biologics

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Characterisation of the vascular and inflammatory lesions induced by the PDE4 inhibitor CI-1044 in the dog.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

An idiopathic febrile necrotizing arteritis syndrome in the dog: beagle pain syndrome

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Experimental immune complex-mediated glomerulonephritis in the nonhuman primate

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

A comparative study of minoxidil-induced myocardial lesions in beagle dogs and miniature swine

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21 January 2018

Characterization, biomarkers, and reversibility of a monoclonal antibody-induced immune complex disease in cynomolgus monkeys (Macaca fascicularis).

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Small-vessel vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Complement in ANCA-associated vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Arterial lesions induced by phosphodiesterase III (PDE III) inhibitors and DA(1) agonists

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Mesenteric arteriopathy in the rat induced by phosphodiesterase III inhibitors: an investigation of morphological, ultrastructural, and hemodynamic changes

1 reference

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21 January 2018

High-molecular-weight aggregates in repackaged bevacizumab

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Complement is crucial in the pathogenesis of ANCA-associated vasculitis.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Drug-induced vascular injury--a quest for biomarkers.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Functional properties of antiendothelial cell antibodies

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Anti-neutrophil cytoplasmic autoantibody pathogenicity revisited: pathogenic versus non-pathogenic anti-neutrophil cytoplasmic autoantibody

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Immunogenicity/hypersensitivity of biologics

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Safety evaluation of recombinant human interleukin-4. II. Clinical studies.

1 reference

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21 January 2018

Safety evaluation of recombinant human interleukin-4. I. Preclinical studies

1 reference

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21 January 2018

Properdin in complement activation and tissue injury

1 reference

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21 January 2018

Life and death cell labeling in the microcirculation of the spontaneously hypertensive rat.

1 reference

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21 January 2018

Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: effects of long-term storage and product mishandling

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21 January 2018

The toxicity of SCH 351591, a novel phosphodiesterase-4 inhibitor, in Cynomolgus monkeys

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Biomarkers and mechanisms of drug-induced vascular injury in non-rodents

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Pathology and pathophysiology of drug-induced arterial injury in laboratory animals and its implications on the evaluation of novel chemical entities for human clinical trials

1 reference

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21 January 2018

Endothelin receptor subtype distribution predisposes coronary arteries to damage

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21 January 2018

Vasculitis in the Palmerston North mouse model of lupus: phenotype and cytokine production profile of infiltrating cells

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21 January 2018

International harmonization of toxicologic pathology nomenclature: an overview and review of basic principles

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21 January 2018

Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets

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21 January 2018

Circulating endothelial cells are elevated in patients with type 2 diabetes mellitus independently of HbA(1)c

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21 January 2018

Angiotensin II cell signaling: physiological and pathological effects in the cardiovascular system

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21 January 2018

Drug-induced vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Pathogenesis of cardiovascular alterations in dogs treated with minoxidil

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Cardiovascular alterations in dogs treated with hydralazine

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21 January 2018

Primary endothelial damage is the mechanism of cardiotoxicity of tubulin-binding drugs

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21 January 2018

Nonclinical safety biomarkers of drug-induced vascular injury: current status and blueprint for the future

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21 January 2018

Lymphocytic vasculitis of the uterus in a patient with melanoma receiving ipilimumab

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21 January 2018

Circulating markers of vascular injury and angiogenesis in antineutrophil cytoplasmic antibody-associated vasculitis

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21 January 2018

Mechanisms of immune-deposit formation and the mediation of immune renal injury

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21 January 2018

Evaluation of plasma von Willebrand factor as a biomarker for acute arterial damage in rats

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21 January 2018

Cell signaling of angiotensin II on vascular tone: novel mechanisms

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21 January 2018

Overview of complement activation and regulation

1 reference

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21 January 2018

Theophylline-induced mesenteric periarteritis in F344/N rats

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21 January 2018

Trojan horses: drug culprits associated with antineutrophil cytoplasmic autoantibody (ANCA) vasculitis

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21 January 2018

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies

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21 January 2018

Antineutrophil cytoplasmic antibodies induce monocyte IL-8 release. Role of surface proteinase-3, alpha1-antitrypsin, and Fcgamma receptors

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21 January 2018

Complement: a key system for immune surveillance and homeostasis

1 reference

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21 January 2018

Complement in immune and inflammatory disorders: pathophysiological mechanisms

1 reference

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21 January 2018

Formation, clearance, deposition, pathogenicity, and identification of biopharmaceutical-related immune complexes: review and case studies

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21 January 2018

Dynamics and plasticity of Weibel-Palade bodies in endothelial cells

1 reference

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21 January 2018

Effects of protein aggregates: an immunologic perspective

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Animal models of antineutrophil cytoplasm antibody-associated vasculitis

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Human hypersensitivity angiitis, an immune complex disease

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Histopathology of incidental findings in cynomolgus monkeys ( macaca fascicularis ) used in toxicity studies

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Rapid morphological brain abnormalities during acute methamphetamine intoxication in the rat: an experimental study using light and electron microscopy

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21 January 2018

Cellular and molecular effects of mechanical stretch on vascular cells and cardiac myocytes

1 reference

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21 January 2018

Wegener's granulomatosis: anti-proteinase 3 antibodies are potent inductors of human endothelial cell signaling and leakage response

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Pathologic features of naturally occurring juvenile polyarteritis in beagle dogs

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

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21 January 2018

Swine as models in biomedical research and toxicology testing

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Blood cytokines as biomarkers of in vivo toxicity in preclinical safety assessment: considerations for their use.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

MicroRNA changes in rat mesentery and serum associated with drug-induced vascular injury

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Detection and characterization of circulating endothelial progenitor cells in normal rat blood

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https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

The role of eNOS phosphorylation in causing drug-induced vascular injury.

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21 January 2018

Safety, activity, and immune correlates of anti-PD-1 antibody in cancer

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21 January 2018

Identification of vascular endothelial genes differentially responsive to fluid mechanical stimuli: cyclooxygenase-2, manganese superoxide dismutase, and endothelial cell nitric oxide synthase are selectively up-regulated by steady laminar shear str

1 reference

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21 January 2018

The impact of immunosuppression on endothelial function

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

HDAC4 mediates development of hypertension via vascular inflammation in spontaneous hypertensive rats

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Immunogenicity of mAbs in non-human primates during nonclinical safety assessment

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Systemic administration of an Fcgamma-Fc(epsilon)-fusion protein in house dust mite sensitive nonhuman primates

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Aggregates in monoclonal antibody manufacturing processes

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Early events in vascular injury in the rat induced by the phosphodiesterase IV inhibitor SCH 351591.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Clinical and laboratory characteristics of drug-induced vasculitic syndromes

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Vascular myofibroblasts. Lessons from coronary repair and remodeling

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Biomarkers of endothelial cell activation serve as potential surrogate markers for drug-induced vascular injury

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Biomarkers of endothelial cell activation: candidate markers for drug-induced vasculitis in patients or drug-induced vascular injury in animals

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

SK&F 95654-induced acute cardiovascular toxicity in Sprague-Dawley rats--histopathologic, electron microscopic, and immunohistochemical studies

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Mechanisms and biomarkers of cardiovascular injury induced by phosphodiesterase inhibitor III SK&F 95654 in the spontaneously hypertensive rat.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Histopathology of vascular injury in Sprague-Dawley rats treated with phosphodiesterase IV inhibitor SCH 351591 or SCH 534385.

1 reference

https://api.crossref.org/works/10.1177%2F0192623315570340

21 January 2018

Identifiers

10.1177/0192623315570340

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

PubMed publication ID

1 reference

Europe PubMed Central

PubMed publication ID

2 September 2017

ResearchGate publication ID

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