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Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals

Regulatory toxicology and pharmacology, 2023-09, Vol.143, p.105449-105449, Article 105449

2023

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3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration

Clinical and translational science, 2021-09, Vol.14 (5), p.1659-1680

2021

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FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations

Regulatory toxicology and pharmacology, 2023-02, Vol.138, p.105327, Article 105327

2023

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An Evaluation of First-in-Human Studies for RNA Oligonucleotides

Nucleic acid therapeutics, 2024-09

2024

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Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future

Regulatory toxicology and pharmacology, 2021-07, Vol.123, p.104953-104953, Article 104953

2021

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An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Regulatory toxicology and pharmacology, 2020-07, Vol.114, p.104662, Article 104662

2020

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Exploring rabbit as a nonrodent species for general toxicology studies

Toxicological sciences, 2024-04, Vol.199 (1), p.29-39

2024

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Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety

International Journal of Toxicology, 2024-10, Vol.43 (5), p.435-455

2024

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Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics

International Journal of Toxicology, 2023-12, Vol.42 (6), p.467-479

2023

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Deficiency of ADAP/Fyb/SLAP-130 Destabilizes SKAP55 in Jurkat T Cells

The Journal of biological chemistry, 2005-06, Vol.280 (25), p.23576-23583

2005

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T cell receptor signaling: beyond complex complexes

The Journal of biological chemistry, 2004-07, Vol.279 (28), p.28827-28830

2004

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Complex Complexes: Signaling at the TCR

Immunity, 1996-09, Vol.5 (3), p.197-205

1996

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Deficiency of PTEN in Jurkat T Cells Causes Constitutive Localization of Itk to the Plasma Membrane and Hyperresponsiveness to CD3 Stimulation

Molecular and Cellular Biology, 2000-09, Vol.20 (18), p.6945-6957

2000

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PTEN permits acute increases in D3‐phosphoinositide levels following TCR stimulation but inhibits distal signaling events by reducing the basal activity of Akt

European journal of immunology, 2004-11, Vol.34 (11), p.3165-3175

2004

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Kinase-Independent Functions for Itk in TCR-Induced Regulation of Vav and the Actin Cytoskeleton

The Journal of immunology (1950), 2005-02, Vol.174 (3), p.1385-1392

2005

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ζ Phosphorylation Without ZAP-70 Activation Induced by TCR Antagonists or Partial Agonists

Science (American Association for the Advancement of Science), 1995-01, Vol.267 (5197), p.515-518

1995

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Genetic Evidence for Differential Coupling of Syk Family Kinases to the T-Cell Receptor: Reconstitution Studies in a ZAP-70-Deficient Jurkat T-Cell Line

Molecular and Cellular Biology, 1998-03, Vol.18 (3), p.1388-1399

1998

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TCR Signaling: Another Abl-Bodied Kinase Joins the Cascade

Current biology, 2004-07, Vol.14 (14), p.R562-R564

Wange, Ronald L

2004

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Itk/Emt/Tsk Activation in Response to CD3 Cross-linking in Jurkat T Cells Requires ZAP-70 and Lat and Is Independent of Membrane Recruitment

The Journal of biological chemistry, 1999-10, Vol.274 (41), p.29323-29330

1999

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Negative regulation of CXCR4-mediated chemotaxis by the lipid phosphatase activity of tumor suppressor PTEN

Blood, 2005-10, Vol.106 (8), p.2619-2626

2005

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Lipid phosphatases in the regulation of T cell activation: living up to their PTEN-tial

Immunological reviews, 2003-04, Vol.192 (1), p.80-97

2003

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PTEN expression in PTEN-null leukaemic T cell lines leads to reduced proliferation via slowed cell cycle progression

Oncogene, 2003-11, Vol.22 (50), p.8195-8204

2003

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Loss of PTEN expression does not contribute to PDK-1 activity and PKC activation-loop phosphorylation in Jurkat leukaemic T cells

Cellular signalling, 2007-12, Vol.19 (12), p.2444-2457

2007

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Activating and Inhibitory Mutations in Adjacent Tyrosines in the Kinase Domain of ZAP-70 (∗)

The Journal of biological chemistry, 1995-08, Vol.270 (32), p.18730-18733

1995

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Involvement of Hematopoietic Progenitor Kinase 1 in T Cell Receptor Signaling

The Journal of biological chemistry, 2001-06, Vol.276 (22), p.18908-18914

2001

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Considerations regarding the use of nonhuman primates in assessing safety endpoints for pharmaceuticals

3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration

FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations

An Evaluation of First-in-Human Studies for RNA Oligonucleotides

Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs)

Exploring rabbit as a nonrodent species for general toxicology studies

Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety

Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics

Deficiency of ADAP/Fyb/SLAP-130 Destabilizes SKAP55 in Jurkat T Cells

T cell receptor signaling: beyond complex complexes

Complex Complexes: Signaling at the TCR

Deficiency of PTEN in Jurkat T Cells Causes Constitutive Localization of Itk to the Plasma Membrane and Hyperresponsiveness to CD3 Stimulation

PTEN permits acute increases in D3‐phosphoinositide levels following TCR stimulation but inhibits distal signaling events by reducing the basal activity of Akt

Kinase-Independent Functions for Itk in TCR-Induced Regulation of Vav and the Actin Cytoskeleton

ζ Phosphorylation Without ZAP-70 Activation Induced by TCR Antagonists or Partial Agonists

Genetic Evidence for Differential Coupling of Syk Family Kinases to the T-Cell Receptor: Reconstitution Studies in a ZAP-70-Deficient Jurkat T-Cell Line

TCR Signaling: Another Abl-Bodied Kinase Joins the Cascade

Itk/Emt/Tsk Activation in Response to CD3 Cross-linking in Jurkat T Cells Requires ZAP-70 and Lat and Is Independent of Membrane Recruitment

Negative regulation of CXCR4-mediated chemotaxis by the lipid phosphatase activity of tumor suppressor PTEN

Lipid phosphatases in the regulation of T cell activation: living up to their PTEN-tial

PTEN expression in PTEN-null leukaemic T cell lines leads to reduced proliferation via slowed cell cycle progression

Loss of PTEN expression does not contribute to PDK-1 activity and PKC activation-loop phosphorylation in Jurkat leukaemic T cells

Activating and Inhibitory Mutations in Adjacent Tyrosines in the Kinase Domain of ZAP-70 (∗)

Involvement of Hematopoietic Progenitor Kinase 1 in T Cell Receptor Signaling

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