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An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors

Birth defects research. Part B. Developmental and reproductive toxicology, 2016-04, Vol.107 (2), p.108-119

2016

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Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies

The AAPS journal, 2018-03, Vol.20 (2), p.28-28, Article 28

2018

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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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Characterization of MK-4166, a Clinical Agonistic Antibody That Targets Human GITR and Inhibits the Generation and Suppressive Effects of T Regulatory Cells

Cancer research (Chicago, Ill.), 2017-08, Vol.77 (16), p.4378-4388

2017

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

Regulatory toxicology and pharmacology, 2009-07, Vol.54 (2), p.164-182

2009

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A T-cell-dependent antibody response study using a murine surrogate anti-PD-1 monoclonal antibody as an alternative to a non-human primate model

Journal of immunotoxicology, 2020-01, Vol.17 (1), p.175-185

2020

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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Lisa Plitnick, Danuta J. Herzyk / Lisa Plitnick, Danuta Herzyk

1, 2013

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The T-dependent antibody response to keyhole limpet hemocyanin in rodents

Methods in molecular biology (Clifton, N.J.), 2010, Vol.598, p.159

2010

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Preclinical efficacy and safety of mepolizumab (SB-240563), a humanized monoclonal antibody to IL-5, in cynomolgus monkeys

Journal of allergy and clinical immunology, 2001-08, Vol.108 (2), p.250-257

2001

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Immunotoxicology Strategies for Pharmaceutical Safety Assessment

1. Aufl., 2008

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Primary antibody response to keyhole limpet hemocyanin in rat as a model for immunotoxicity evaluation

Toxicology (Amsterdam), 2004-04, Vol.197 (1), p.23-35

2004

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Immunotoxicity Evaluation by Immune Function Tests: Focus on the T-Dependent Antibody Response (TDAR) [Overview of a Workshop Session at the 45th Annual Meeting of the Society of Toxicology (SOT) March 5-9, 2006 San Diego, CA]

Journal of immunotoxicology, 2007-04, Vol.4 (2), p.143-147

2007

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Nonclinical safety of tildrakizumab, a humanized anti–IL-23p19 monoclonal antibody, in nonhuman primates

Regulatory toxicology and pharmacology, 2019-11, Vol.108, p.104476, Article 104476

2019

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Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis

Toxicological sciences, 2024-06, Vol.200 (1), p.11-30

2024

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Immunomodulatory Effects of Anti-CD4 Antibody in Host Resistance against Infections and Tumors in Human CD4 Transgenic Mice

Infection and Immunity, 2001-02, Vol.69 (2), p.1032-1043

2001

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Comparison of immune function tests using T-cell dependent antigens: A meta-analysis

Toxicology letters, 2009-09, Vol.189, p.S42-S42

Herzyk, Danuta

2009

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Adequate immunotoxicity testing in drug development

Toxicology letters, 2004-04, Vol.149 (1), p.115-122

2004

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Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

Regulatory toxicology and pharmacology, 2023-02, Vol.138, p.105329, Article 105329

2023

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Preclinical Safety of Recombinant Human Interleukin-18

Toxicologic pathology, 2003-09, Vol.31 (5), p.554-561

2003

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The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain

Regulatory toxicology and pharmacology, 2023-02, Vol.138, p.105339, Article 105339

2023

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Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies

Regulatory toxicology and pharmacology, 2021-02, Vol.119, p.104825, Article 104825

2021

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Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs

Journal of immunotoxicology, 2009-03, Vol.6 (1), p.1-10

2009

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Assessing immunotoxicity of pharmaceuticals: the need for enhanced testing

Fundamental & clinical pharmacology, 2005-06, Vol.19 (3), p.323-328

Herzyk, Danuta J.

2005

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Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species

Clinical immunology (Orlando, Fla.), 2003-11, Vol.109 (2), p.188-196

2003

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An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors

Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies

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

Characterization of MK-4166, a Clinical Agonistic Antibody That Targets Human GITR and Inhibits the Generation and Suppressive Effects of T Regulatory Cells

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

A T-cell-dependent antibody response study using a murine surrogate anti-PD-1 monoclonal antibody as an alternative to a non-human primate model

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

The T-dependent antibody response to keyhole limpet hemocyanin in rodents

Preclinical efficacy and safety of mepolizumab (SB-240563), a humanized monoclonal antibody to IL-5, in cynomolgus monkeys

Immunotoxicology Strategies for Pharmaceutical Safety Assessment

Primary antibody response to keyhole limpet hemocyanin in rat as a model for immunotoxicity evaluation

Immunotoxicity Evaluation by Immune Function Tests: Focus on the T-Dependent Antibody Response (TDAR) [Overview of a Workshop Session at the 45th Annual Meeting of the Society of Toxicology (SOT) March 5-9, 2006 San Diego, CA]

Nonclinical safety of tildrakizumab, a humanized anti–IL-23p19 monoclonal antibody, in nonhuman primates

Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis

Immunomodulatory Effects of Anti-CD4 Antibody in Host Resistance against Infections and Tumors in Human CD4 Transgenic Mice

Comparison of immune function tests using T-cell dependent antigens: A meta-analysis

Adequate immunotoxicity testing in drug development

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

Preclinical Safety of Recombinant Human Interleukin-18

The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain

Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies

Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs

Assessing immunotoxicity of pharmaceuticals: the need for enhanced testing

Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab

Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species

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