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1

Adequate immunotoxicity testing in drug development

Danuta J Herzyk, Elizabeth R Gore

Journal:

Toxicology Letters

Year:

2004

Language:

english

File:

PDF, 100 KB

english, 2004

2

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

Piccotti, Joseph R., Lebrec, Herve N., Evans, Ellen, Herzyk, Danuta J., Hastings, Kenneth L., Burns-Naas, Leigh Ann, Gourley, Ian S., Wierda, Daniel, Kawabata, Thomas T.

Journal:

Journal of Immunotoxicology

Year:

2009

Language:

english

File:

PDF, 597 KB

english, 2009

3

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

Poulet, Frederique M., Wolf, Jayanthi J., Herzyk, Danuta J., DeGeorge, Joseph J.

Journal:

Birth Defects Research Part B: Developmental and Reproductive Toxicology

Year:

2016

Language:

english

File:

PDF, 514 KB

english, 2016

4

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Antidrug Antibody Responses in Nonclinical Studies and their Implications

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 167 KB

english, 2008

5

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

MacLachlan, Timothy K., Kronenberg, Sven, Marshall, Nikki, Andrews, Laura, Berens, Shawn Jay, Brouta, Frederic, Fogal, Birgit, Freebern, Wendy, Herzyk, Danuta, Kamperschroer, Cris, Kiessling, Andrea,

Journal:

Regulatory Toxicology and Pharmacology

Year:

2020

File:

PDF, 1.71 MB

2020

6

Atiprimod (SKandF 106615), a novel macrophage targeting agent, enhances alveolar macrophage candidacidal activity and is not immunosuppresive in candida-infected mice

Alison M. Badger, Jeffrey A. Handler, Caroline A. Genell, Danuta Herzyk, Elizabeth Gore, Rodd Polsky, Lee Webb, Peter J. Bugelski

Journal:

International Journal of Immunopharmacology

Year:

1999

Language:

english

File:

PDF, 418 KB

english, 1999

7

Relationships between antibodies against human soluble complement receptor 1 (hsCR1) from various species

Elizabeth V. Ruggieri, Peter J. Bugelski, Johanne M. Kaplan, Daniel Everitt, John Lipani, Diane K. Jorkasky, Steven C. Boike, Frederick DeClement, Francis D. Moore, Danuta J. Herzyk

Journal:

Journal of Clinical Immunology

Year:

1996

Language:

english

File:

PDF, 896 KB

english, 1996

8

Effect of TNFα production inhibitors BRL 61063 and pentoxifylline on the response of rats to poly I:C

Johanne M. Kaplan, , Danuta J. Herzyk, Elizabeth V. Ruggieri, Joan O'leary bartus, Klaus M. Esser, Peter J. Bugelski

Journal:

Year:

1995

Language:

english

File:

PDF, 1010 KB

english, 1995

9

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

Elizabeth R. Gore, Jill Gower, Edit Kurali, Jui-Lan Sui, Jane Bynum, Daniela Ennulat, Danuta J. Herzyk

Journal:

Year:

2004

Language:

english

File:

PDF, 244 KB

english, 2004

10

Assessing immunotoxicity of pharmaceuticals: the need for enhanced testing

Danuta J. Herzyk

Journal:

Fundamental & Clinical Pharmacology

Year:

2005

Language:

english

File:

PDF, 82 KB

english, 2005

11

Behaviour of microelements in lung cancer patients

Michat Masiak, Danuta Herzyk

Journal:

Analytical and Bioanalytical Chemistry

Year:

1984

Language:

english

File:

PDF, 179 KB

english, 1984

12

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

Rafael Ponce, Leslie Abad, Lakshmi Amaravadi, Thomas Gelzleichter, Elizabeth Gore, James Green, Shalini Gupta, Danuta Herzyk, Christopher Hurst, Inge A. Ivens, Thomas Kawabata, Curtis Maier, Barbara M

Journal:

Regulatory Toxicology and Pharmacology

Year:

2009

Language:

english

File:

PDF, 583 KB

english, 2009

13

IMMUNOPHARMACOLOGY OF RECOMBINANT HUMAN INTERLEUKIN-18 IN NON-HUMAN PRIMATES

Danuta J. Herzyk, Jeanne M. Soos, Curtis C. Maier, Elizabeth R. Gore, Padma K. Narayanan, Kimberly L. Nadwodny, Susan Liu, Zdenka L. Jonak, Peter J. Bugelski

Journal:

Year:

2002

Language:

english

File:

PDF, 362 KB

english, 2002

14

FP 10 Macaque anti-human antibodies: Analysis of the host response to a therapeutic humanized antibody

Elizabeth R. Gore, Danuta J. Herzyk, Sandra D. Griego, Charles B. Davis, Carol Silverman, Peter J. Bugelski, Timothy K. Hart

Journal:

Developmental & Comparative Immunology

Year:

1997

Language:

english

File:

PDF, 98 KB

english, 1997

15

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

Jeanne M Soos, Rodd M Polsky, Sean P Keegan, Peter Bugelski, Danuta J Herzyk

Journal:

Clinical Immunology

Year:

2003

Language:

english

File:

PDF, 183 KB

english, 2003

16

Sandwich ELISA formats designed to detect 17 kDa IL-1β significantly underestimate 35 kDa IL-1β

Danuta J. Herzyk, Ann E. Berger, James N. Allen, Mark D. Wewers

Journal:

Journal of Immunological Methods

Year:

1992

Language:

english

File:

PDF, 658 KB

english, 1992

17

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

Journal:

Toxicology Letters

Year:

2009

Language:

english

File:

PDF, 54 KB

english, 2009

18

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics || Overview of Biosimilar Therapeutics

Herzyk, Danuta J.

Year:

2013

Language:

english

File:

PDF, 190 KB

english, 2013

19

Vaccines Europe reflection paper on the safety assessment of residuals and contaminants in vaccines

Damsten, Micaela, Segal, Lawrence, Gould, Sarah, Finkelstein, Martin, Frantz, Christopher, Geuns, Ed, Herzyk, Danuta, Mulder, Mariska, Novicki, Deborah, Smith, Thomas

Journal:

Toxicology Letters

Year:

2013

Language:

english

File:

PDF, 71 KB

english, 2013

20

Tumor Necrosis Factor Increases the Elastolytic Potential of Adherent Neutrophils: A Role for Hypochlorous Acid

She, Zhi-Wu, Wewers, Mark D., Herzyk, Danuta J., Davis, W. Bruce

Journal:

American Journal of Respiratory Cell and Molecular Biology

Year:

1993

Language:

english

File:

PDF, 768 KB

english, 1993

21

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]

Herzyk, Danuta J., Holsapple, Michael

Journal:

Journal of Immunotoxicology

Year:

2007

Language:

english

File:

PDF, 135 KB

english, 2007

22

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Animal Models for Preclinical Comparative Immunogenicity Testing

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 369 KB

english, 2008

23

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Alternative Animal Models for Immunomodulation and Immunotoxicity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 216 KB

english, 2008

24

ELISA Detection of IL-Iβ in Human Sera Needs Independent Confirmation: False Positives in Hospitalized Patients

Herzyk, Danuta J., Wewers, Mark D.

Journal:

American Review of Respiratory Disease

Year:

1993

Language:

english

File:

PDF, 406 KB

english, 1993

25

High-Dose Recombinant Interleukin-18 Induces an Effective Th1 Immune Response to Murine MOPC-315 Plasmacytoma

Jonak, Zdenka L., Trulli, Stephen, Maier, Curtis, McCabe, Francis L., Kirkpatrick, Robert, Johanson, Kyung, Ho, Yen Sen, Elefante, Louis, Chen, Yi-Jiun, Herzyk, Danuta, Lotze, Michael T., Johnson, Ran

Journal:

Journal of Immunotherapy

Year:

2002

Language:

english

File:

PDF, 678 KB

english, 2002

26

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Immunotoxicological Concerns for Vaccines and Adjuvants

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 144 KB

english, 2008

27

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Clinical Pathology as Crucial Insight into Immunotoxicity Testing

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 178 KB

english, 2008

28

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Histomorphology of the Immune System: A Basic Step in Assessing Immunotoxicity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 13.01 MB

english, 2008

29

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || T Cell-Dependent Antibody Response Tests

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 193 KB

english, 2008

30

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

Herzyk, Danuta J., Haggerty, Helen G.

Journal:

The AAPS Journal

Year:

2018

Language:

english

File:

PDF, 457 KB

english, 2018

31

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Specific Drug-Induced Immunotoxicity: Immune-Mediated Hemolytic Anemia

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 684 KB

english, 2008

32

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Pharmacological Immunogenicity and Adverse Responses to Vaccines

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 151 KB

english, 2008

33

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Application of Flow Cytometry in Drug Development

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 220 KB

english, 2008

34

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Bridging Immunotoxicology to Clinical Drug Development

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 114 KB

english, 2008

35

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Functional Cellular Responses and Cytokine Profiles

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 155 KB

english, 2008

36

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || T Cell Epitopes and Minimization of Immunogenicity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 530 KB

english, 2008

37

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Systemic Hypersensitivity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 321 KB

english, 2008

38

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Differentiation between Desired Immunomodulation and Potential Immunotoxicity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 126 KB

english, 2008

39

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Cellular Immune Response in Delayed-Type Hypersensitivity Tests

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 3.21 MB

english, 2008

40

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Animal Models of Host Resistance

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 210 KB

english, 2008

41

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Need for Specialized Immunotoxicity Tests

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 3.16 MB

english, 2008

42

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Approaches to Evaluation of Autoimmunity

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 147 KB

english, 2008

43

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Natural Killer Cell Assay and Other Innate Immunity Tests

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 144 KB

english, 2008

44

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Current Regulatory Expectations for Immunotoxicology Evaluation of Pharmaceuticals

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 112 KB

english, 2008

45

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Developmental Immunotoxicity in Nonhuman Primates

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 346 KB

english, 2008

46

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Developmental Immunotoxicity in Rodents

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 300 KB

english, 2008

47

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Relevant Immune Tests across Different Species and Surrogate Models

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 144 KB

english, 2008

48

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Evaluation of Drug Effects on Immune Cell Phenotypes

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 185 KB

english, 2008

49

Immunotoxicology Strategies for Pharmaceutical Safety Assessment (Herzyk/Immunotoxicology) || Nonclinical Models to Assess Respiratory Hypersensitivity Potential

Herzyk, Danuta J., Bussiere, Jeanine L.

Year:

2008

Language:

english

File:

PDF, 152 KB

english, 2008

50

Drug safety Africa: An overview of safety pharmacology & toxicology in South Africa

Guth, Brian D., Grobler, Anne F., Frazier, Kendall S., Greiter-Wilke, Andrea, Herzyk, Danuta, Hough, Tertius A., Khan, Asrar Ali, Markert, Michael, Smith, James D., Svenson, Karen L., Wells, Sara, Pug

Journal:

Journal of Pharmacological and Toxicological Methods

Year:

2019

Language:

english

File:

PDF, 532 KB

english, 2019