UB Paderborn / Katalog / Suche / in CDI

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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Differential hepatocyte toxicity of recombinant Apo2L/TRAIL versions

Nature medicine, 2001-04, Vol.7 (4), p.383-385

2001

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The Role of the Study Director in Nonclinical Studies: Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

1, 2014

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Biosimilars 2.0: Guiding principles for a global "patients first" standard

mAbs, 2011-05, Vol.3 (3), p.318-325

2011

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Survey results on the use of the tissue cross-reactivity immunohistochemistry assay

Regulatory toxicology and pharmacology, 2011-04, Vol.59 (3), p.493-502

2011

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Antitherapeutic antibody-mediated hepatotoxicity of recombinant human Apo2L/TRAIL in the cynomolgus monkey

Cell death & disease, 2016-08, Vol.7 (8), p.e2338-e2338

2016

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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro

Toxicology and applied pharmacology, 1999-09, Vol.159 (2), p.125-133

1999

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Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate?

Regulatory toxicology and pharmacology, 2008-02, Vol.50 (1), p.2-22

2008

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Pharmacokinetics and safety of a fully human hepatocyte growth factor antibody, AMG 102, in cynomolgus monkeys

Pharmaceutical research, 2007-10, Vol.24 (10), p.1910-1918

2007

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Cytokines: The Good, the Bad, and the Deadly

International journal of toxicology, 2015-07, Vol.34 (4), p.355-365

2015

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Uses and Future Applications of Flow Cytometry in Immunotoxicity Testing

Methods (San Diego, Calif.), 1999-09, Vol.19 (1), p.28-35

1999

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The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment

Current pain and headache reports, 2015, Vol.19 (2), p.2, Article 2

2015

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Abstract SY03-02: Preclinical assessment of JTX-2011, an agonist antibody targeting ICOS, supports evaluation in ICONIC clinical trial

Cancer research (Chicago, Ill.), 2017-07, Vol.77 (13_Supplement), p.SY03-02-SY03-02

2017

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An Introduction to the Regulatory and Nonclinical Aspects of the Nonclinical Development of Antibody Drug Conjugates

Pharmaceutical research, 2015-11, Vol.32 (11), p.3584-3592

2015

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Alterations in Human B Cell Calcium Homeostasis by Polycyclic Aromatic Hydrocarbons: Possible Associations with Cytochrome P450 Metabolism and Increased Protein Tyrosine Phosphorylation

Toxicology and applied pharmacology, 1998-03, Vol.149 (1), p.80-89

1998

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Global Regulatory Standards for the Approval of Biosimilars

Food and drug law journal, 2010-01, Vol.65 (4), p.819-837

2010

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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro

Toxicology and applied pharmacology, 2002-03, Vol.159 (2)

2002

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Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges

The Role of the Study Director in Nonclinical Studies, 2014, p.405-426

2014

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Depletion of Glutathione by Benzo(a)pyrene Metabolites, Ionomycin, Thapsigargin, and Phorbol Myristate in Human Peripheral Blood Mononuclear Cells

Toxicology and applied pharmacology, 1997-05, Vol.144 (1), p.62-69

1997

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Characterization of Intracellular Calcium Responses Produced by Polycyclic Aromatic Hydrocarbons in Surface Marker-Defined Human Peripheral Blood Mononuclear Cells

Toxicology and applied pharmacology, 1997-08, Vol.145 (2), p.323-330

1997

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Concomitant Administration of Bevacizumab, Irinotecan, 5-Fluorouracil, and Leucovorin: Nonclinical Safety and Pharmacokinetics

International journal of toxicology, 2005-09, Vol.24 (5), p.357-363

2005

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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Anti-apoptotic Effects of Peroxisome Proliferators In Vitro

Toxicology and applied pharmacology, 1999-09, Vol.159 (2)

1999

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Regulatory Standards for the Approval of Biosimilar Products: A Global Review

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics, 2013, p.159-184

Mounho-Zamora, Barbara

2013

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Antidrug Antibody Responses in Nonclinical Studies and their Implications

Immunotoxicology Strategies for Pharmaceutical Safety Assessment, 2008, p.209-215

2008

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Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit

The Role of the Study Director in Nonclinical Studies, 2014, p.7-25

2014

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

Differential hepatocyte toxicity of recombinant Apo2L/TRAIL versions

The Role of the Study Director in Nonclinical Studies: Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

Biosimilars 2.0: Guiding principles for a global "patients first" standard

Survey results on the use of the tissue cross-reactivity immunohistochemistry assay

Antitherapeutic antibody-mediated hepatotoxicity of recombinant human Apo2L/TRAIL in the cynomolgus monkey

The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro

Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate?

Pharmacokinetics and safety of a fully human hepatocyte growth factor antibody, AMG 102, in cynomolgus monkeys

Cytokines: The Good, the Bad, and the Deadly

Uses and Future Applications of Flow Cytometry in Immunotoxicity Testing

The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment

Abstract SY03-02: Preclinical assessment of JTX-2011, an agonist antibody targeting ICOS, supports evaluation in ICONIC clinical trial

An Introduction to the Regulatory and Nonclinical Aspects of the Nonclinical Development of Antibody Drug Conjugates

Alterations in Human B Cell Calcium Homeostasis by Polycyclic Aromatic Hydrocarbons: Possible Associations with Cytochrome P450 Metabolism and Increased Protein Tyrosine Phosphorylation

Global Regulatory Standards for the Approval of Biosimilars

The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro

Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges

Depletion of Glutathione by Benzo(a)pyrene Metabolites, Ionomycin, Thapsigargin, and Phorbol Myristate in Human Peripheral Blood Mononuclear Cells

Characterization of Intracellular Calcium Responses Produced by Polycyclic Aromatic Hydrocarbons in Surface Marker-Defined Human Peripheral Blood Mononuclear Cells

Concomitant Administration of Bevacizumab, Irinotecan, 5-Fluorouracil, and Leucovorin: Nonclinical Safety and Pharmacokinetics

The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Anti-apoptotic Effects of Peroxisome Proliferators In Vitro

Regulatory Standards for the Approval of Biosimilar Products: A Global Review

Antidrug Antibody Responses in Nonclinical Studies and their Implications

Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit

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