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CSL-Tox: an open-source analytical framework for the comparison of short-term and long-term toxicity end points and assessing the need of chronic studies in drug development

Scientific reports, 2023-09, Vol.13 (1), p.14865-16, Article 14865

2023

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Nonclinical Toxicology and Biocompatibility Program Supporting Clinical Development and Registration of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration

Toxicologic pathology, 2021-04, Vol.49 (3), p.663-672

2021

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EVALUATION OF SURGICAL FACTORS AFFECTING VITREOUS HEMORRHAGE FOLLOWING PORT DELIVERY SYSTEM WITH RANIBIZUMAB IMPLANT INSERTION IN A MINIPIG MODEL

Retina (Philadelphia, Pa.), 2020-08, Vol.40 (8), p.1520-1528

2020

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Inflammation of a Posterior Ciliary Artery in a Naive Cynomolgus Macaque

Toxicologic pathology, 2021-04, Vol.49 (3), p.602-604

2021

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Uncovering of intraspecies macular heterogeneity in cynomolgus monkeys using hybrid machine learning optical coherence tomography image segmentation

Scientific reports, 2021-10, Vol.11 (1), p.20647-20647, Article 20647

2021

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Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies

Toxicologic pathology, 2022-02, Vol.50 (2), p.235-251

2022

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Degree of Cajal-Retzius Cell Mislocalization Correlates with the Severity of Structural Brain Defects in Mouse Models of Dystroglycanopathy

Brain pathology (Zurich, Switzerland), 2016-07, Vol.26 (4), p.465-478

2016

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Identification and characterization of an octameric PEG-protein conjugate system for intravitreal long-acting delivery to the back of the eye

PloS one, 2019-06, Vol.14 (6), p.e0218613

2019

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International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

Clinical and translational science, 2023-05, Vol.16 (5), p.723-741

2023

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The transgenic expression of LARGE exacerbates the muscle phenotype of dystroglycanopathy mice

Human molecular genetics, 2014-04, Vol.23 (7), p.1842-1855

2014

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Intravitreal RTH258 (brolucizumab) demonstrates no effect on pregnancy, parturition, embryofetal or postnatal development in cynomolgus monkeys

Reproductive toxicology (Elmsford, N.Y.), 2023-10, Vol.121, p.108468, Article 108468

2023

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Foreign Body Reaction, Retinal Degeneration, and Epiretinal Membranes Associated With Intravitreal Administration of PLGA Rods

Toxicologic pathology, 2021-04, Vol.49 (3), p.656-662

2021

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Nonclinical Safety Assessment of FHTR2163, An Antigen-Binding Fragment Against HTRA1 for the Treatment of Geographic Atrophy

Toxicologic pathology, 2021-04, Vol.49 (3), p.610-620

2021

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Congenital Intrahepatic Vascular Anomaly in a Clinically Normal Laboratory Beagle

Toxicologic pathology, 2008-12, Vol.36 (7), p.981-984

Booler, Helen

2008

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Antibody semorinemab reduces tau pathology in a transgenic mouse model and engages tau in patients with Alzheimer's disease

Science translational medicine, 2021-05, Vol.13 (593)

2021

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Intravitreal Administration of Acetyl Triethyl Citrate and Benzyl Benzoate Is Retinotoxic in Rabbits but Not in Cynomolgus Monkeys

Toxicologic pathology, 2021-04, Vol.49 (3), p.621-633

2021

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An Anti-CD22- seco -CBI-Dimer Antibody-Drug Conjugate (ADC) for the Treatment of Non-Hodgkin Lymphoma That Provides a Longer Duration of Response than Auristatin-Based ADCs in Preclinical Models

Molecular cancer therapeutics, 2021-02, Vol.20 (2), p.340-346

2021

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Discovery of TRPA1 Antagonist GDC-6599: Derisking Preclinical Toxicity and Aldehyde Oxidase Metabolism with a Potential First-in-Class Therapy for Respiratory Disease

Journal of medicinal chemistry, 2024-03, Vol.67 (5), p.3287-3306

2024

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Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation

Regulatory toxicology and pharmacology, 2020-06, Vol.113, p.104624, Article 104624

2020

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Retinal Features in Cynomolgus Macaques (Macaca fascicularis) Assessed by Using Scanning Laser Ophthalmoscopy and Spectral Domain Optical Coherence Tomography

Comparative medicine, 2020-04, Vol.70 (2), p.145-151

2020

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Determination of a No-Observable Effect Level for Endotoxin Following a Single Intravitreal Administration to Dutch Belted Rabbits

Investigative ophthalmology & visual science, 2017-03, Vol.58 (3), p.1545-1552

2017

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Rapid Development of Glaucoma Via ITV Nonselective ANGPT 1/2 Antibody: A Potential Role for ANGPT/TIE2 Signaling in Primate Aqueous Humor Outflow

Investigative ophthalmology & visual science, 2019-10, Vol.60 (13), p.4097-4108

2019

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D egree of C ajal– R etzius Cell Mislocalization Correlates with the Severity of Structural Brain Defects in Mouse Models of Dystroglycanopathy

Brain pathology (Zurich, Switzerland), 2016-07, Vol.26 (4), p.465-478

2016

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Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics

Journal of ocular pharmacology and therapeutics, 2018-01, Vol.34 (1-2), p.204-213

2018

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Conjunctival bacterial and fungal flora in healthy horses in the UK

Veterinary ophthalmology, 2011-05, Vol.14 (3), p.195-199

2011

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CSL-Tox: an open-source analytical framework for the comparison of short-term and long-term toxicity end points and assessing the need of chronic studies in drug development

Nonclinical Toxicology and Biocompatibility Program Supporting Clinical Development and Registration of the Port Delivery System With Ranibizumab for Neovascular Age-Related Macular Degeneration

EVALUATION OF SURGICAL FACTORS AFFECTING VITREOUS HEMORRHAGE FOLLOWING PORT DELIVERY SYSTEM WITH RANIBIZUMAB IMPLANT INSERTION IN A MINIPIG MODEL

Inflammation of a Posterior Ciliary Artery in a Naive Cynomolgus Macaque

Uncovering of intraspecies macular heterogeneity in cynomolgus monkeys using hybrid machine learning optical coherence tomography image segmentation

Scientific and Regulatory Policy Committee Points to Consider: Fixation, Trimming, and Sectioning of Nonrodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies

Degree of Cajal-Retzius Cell Mislocalization Correlates with the Severity of Structural Brain Defects in Mouse Models of Dystroglycanopathy

Identification and characterization of an octameric PEG-protein conjugate system for intravitreal long-acting delivery to the back of the eye

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs

The transgenic expression of LARGE exacerbates the muscle phenotype of dystroglycanopathy mice

Intravitreal RTH258 (brolucizumab) demonstrates no effect on pregnancy, parturition, embryofetal or postnatal development in cynomolgus monkeys

Foreign Body Reaction, Retinal Degeneration, and Epiretinal Membranes Associated With Intravitreal Administration of PLGA Rods

Nonclinical Safety Assessment of FHTR2163, An Antigen-Binding Fragment Against HTRA1 for the Treatment of Geographic Atrophy

Congenital Intrahepatic Vascular Anomaly in a Clinically Normal Laboratory Beagle

Antibody semorinemab reduces tau pathology in a transgenic mouse model and engages tau in patients with Alzheimer's disease

Intravitreal Administration of Acetyl Triethyl Citrate and Benzyl Benzoate Is Retinotoxic in Rabbits but Not in Cynomolgus Monkeys

An Anti-CD22- seco -CBI-Dimer Antibody-Drug Conjugate (ADC) for the Treatment of Non-Hodgkin Lymphoma That Provides a Longer Duration of Response than Auristatin-Based ADCs in Preclinical Models

Discovery of TRPA1 Antagonist GDC-6599: Derisking Preclinical Toxicity and Aldehyde Oxidase Metabolism with a Potential First-in-Class Therapy for Respiratory Disease

Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation

Retinal Features in Cynomolgus Macaques (Macaca fascicularis) Assessed by Using Scanning Laser Ophthalmoscopy and Spectral Domain Optical Coherence Tomography

Determination of a No-Observable Effect Level for Endotoxin Following a Single Intravitreal Administration to Dutch Belted Rabbits

Rapid Development of Glaucoma Via ITV Nonselective ANGPT 1/2 Antibody: A Potential Role for ANGPT/TIE2 Signaling in Primate Aqueous Humor Outflow

D egree of C ajal– R etzius Cell Mislocalization Correlates with the Severity of Structural Brain Defects in Mouse Models of Dystroglycanopathy

Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics

Conjunctival bacterial and fungal flora in healthy horses in the UK

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