Evelyne Polack

Scientific and Regulatory Policy Committee Best Practices: Recommended (“Best”) Practices for Informed (Non-blinded) Versus Masked (Blinded) Microscopic Evaluation in Animal Toxicity Studies

Brad N. Bolon, Sabine Francke, Jessica M. Caverly Rae, Evelyne Polack et autres

This article describes the Society of Toxicologic Pathology's (STP) five recommended ("best") practices for appropriate use of informed (non-blinded) versus masked (blinded) microscopic evaluation in animal toxicity studies intended for regulatory review. (1) Informed microscopic evaluation is the default approach for animal …

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Discovery and Preclinical Characterization of BIIB091, a Reversible, Selective BTK Inhibitor for the Treatment of Multiple Sclerosis

Brian T. Hopkins, Eris Bame, Bekim Bajrami, Cheryl Black et autres

Multiple Sclerosis is a chronic autoimmune neurodegenerative disorder of the central nervous system (CNS) that is characterized by inflammation, demyelination, and axonal injury leading to permeant disability. In the early stage of MS, inflammation is the primary driver of the disease progression. …

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Discovery of BIIB068: A Selective, Potent, Reversible Bruton’s Tyrosine Kinase Inhibitor as an Orally Efficacious Agent for Autoimmune Diseases

Bin Ma, Tonika Bohnert, Kevin L. Otipoby, Eric S. Tien et autres

Abstract Autoreactive B cell-derived antibodies form immune complexes that likely play a pathogenic role in autoimmune diseases. In systemic lupus erythematosus (SLE), these antibodies bind Fc receptors on myeloid cells and induce proinflammatory cytokine production by monocytes and NETosis by neutrophils. Bruton’s …

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Opinion on Current Use of Non-Blinded Versus Blinded Histopathologic Evaluation in Animal Toxicity Studies

Brad N. Bolon, Jessica M. Caverly Rae, Karyn A. Colman, Sabine Francke et autres

The Society of Toxicologic Pathology (STP) explored current institutional practices for selecting between non-blinded versus blinded histopathologic evaluation during Good Laboratory Practice (GLP)-compliant, regulatory-type animal toxicity studies using a multi-question survey and STP-wide discussion (held at the 2019 STP annual meeting). Survey …

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Toxicologic Pathology Forum Opinion Piece: Current Use of Non-blinded vs. Blinded Histopathologic Evaluation in Animal Toxicity Studies

Brad N. Bolon, Jessica Caverly Rae, Karyn A. Colman, Sabine Francke et autres

The Society of Toxicologic Pathology (STP) explored current institutional practices for selecting between non-blinded vs. blinded histopathologic evaluation during Good Laboratory Practice (GLP)-compliant, regulatory-type animal toxicity studies using a multi-question survey and STP-wide discussion at the 2019 STP annual meeting. Survey responses …

In Vivo Pharmacology and Toxicology Evaluation of Polyethylene Glycol-Conjugated Interferon β-1a

Xiao Shelley Hu, Kenneth N. Olivier, Evelyne Polack, Mary Crossman et autres

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Use of Tissue Cross-reactivity Studies in the Development of Antibody-based Biopharmaceuticals

Michael W. Leach, Wendy Halpern, Carol W. Johnson, Jennifer L. Rojko et autres

Tissue cross-reactivity (TCR) studies are screening assays recommended for antibody and antibody-like molecules that contain a complementarity-determining region (CDR), primarily to identify off-target binding and, secondarily, to identify sites of on-target binding that were not previously identified. At the present time, TCR …

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Sustained overexpression of FoxM1B which increases liver regenerative capacity may have minimal effects on hepatocellular carcinoma development

Olga A. Kalinina, Sergey A. Kalinin, Evelyne Polack, Igor Mikaelian et autres

5056 FoxM1B is a member of the Forkhead box (Fox) transcription factor family whose members play important roles in regulating embryogenesis, cellular proliferation, cellular differentiation and longevity. Expression of FoxM1B correlates with cell proliferation; it is present in rapidly dividing embryonic tissues …

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Aspectos histopatológicos da reação inflamatória em bovinos parasitados por larvas (L3) de Dermatobia hominis (Linnaeus Jr., 1781)

Simone Benghi Pinto, Vanete Thomaz‐Soccol, Evelyne Polack, João Caetano Fortes et autres

Linnaeus Jr.,

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Sustained hepatic expression of FoxM1B in transgenic mice has minimal effects on hepatocellular carcinoma development but increases cell proliferation rates in preneoplastic and early neoplastic lesions

Olga A. Kalinina, Sergey A. Kalinin, Evelyne Polack, Igor Mikaelian et autres

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Concentrations of trace minerals in the spinal cord of horses with equine motor neuron disease

Evelyne Polack, John Μ. King, John F. Cummings, Hussni Omar Mohammed et autres

OBJECTIVE: To compare concentrations of trace minerals in the spinal cord of horses with equine motor neuron disease (EMND) with those of horses without neurologic disease (control horses). ANIMALS: 24 horses with EMND and 22 control horses. PROCEDURE: Spinal cord trace mineral …

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Intestinal haemorrhage associated with colonic vascular ectasia (angiodysplasia) in a dog

Timothy M. Fan, Kenneth William Simpson, Evelyne Polack, N.L. Dykes et autres

An eight-year-old, sexually intact, male, 37 kg crossbred dog was referred for investigation of two acute episodes of intestinal bleeding and severe anaemia within a five-month period. There was no evidence of coagulopathy or underlying systemic disease. Technetium-labelled red blood cell scintigraphy …

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