Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases (Q38208275)

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scientific article published on 29 April 2014

Language	Label	Description	Also known as
English	Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases	scientific article published on 29 April 2014

Statements

scholarly article

1 reference

Europe PubMed Central

31 August 2017

Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases (English)

1 reference

Europe PubMed Central

31 August 2017

monoclonal antibody

1 reference

based on heuristic

inferred from title

author name string

Frank R Brennan

1

1 reference

Europe PubMed Central

31 August 2017

Annick Cauvin

2

1 reference

Europe PubMed Central

31 August 2017

Jay Tibbitts

3

1 reference

Europe PubMed Central

31 August 2017

Alison Wolfreys

4

1 reference

Europe PubMed Central

31 August 2017

publication date

29 April 2014

1 reference

Europe PubMed Central

31 August 2017

Drug Development Research

1 reference

Europe PubMed Central

31 August 2017

75

1 reference

Europe PubMed Central

31 August 2017

115-161

1 reference

Europe PubMed Central

31 August 2017

3

1 reference

Europe PubMed Central

31 August 2017

Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics

1 reference

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scFv antibody: principles and clinical application

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Immunogenicity and autoimmunity during anti-TNF therapy.

1 reference

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Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator.

1 reference

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Safety evaluation of biological drugs: what are toxicology studies in primates telling us?

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Human papilloma virus infection and skin cancer in renal allograft recipients

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Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry

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Monoclonal antibodies in MS: mechanisms of action

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Engineering novel binding proteins from nonimmunoglobulin domains

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TCR stimulation with modified anti-CD3 mAb expands CD8+ T cell population and induces CD8+CD25+ Tregs

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Embryo-fetal developmental toxicity of figitumumab, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in cynomolgus monkeys.

1 reference

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Placental transfer of Fc-containing biopharmaceuticals across species, an industry survey analysis

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Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

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Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses.

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Antitumor and antimetastatic activity of interleukin 12 against murine tumors

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Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets

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Preclinical development of keliximab, a Primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies.

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Critical review of preclinical approaches to evaluate the potential of immunosuppressive drugs to influence human neoplasia

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Influenza virus host resistance model

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Testing human biologicals in animal host resistance models

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What's so special about the developing immune system?

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Alternative strategies for toxicity testing of species-specific biopharmaceuticals

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Taking immunogenicity assessment of therapeutic proteins to the next level.

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Characterization of 47 MHC class I sequences in Filipino cynomolgus macaques

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A comparison of effects on reproduction and neonatal development in cynomolgus monkeys given human soluble IL-4R and mice given murine soluble IL-4R.

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Epstein Barr virus-associated lymphoproliferative-disorders primarily involving the skin

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Pregnancy outcomes after maternal exposure to rituximab

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Preclinical development of monoclonal antibodies: considerations for the use of non-human primates

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The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.

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Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose

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Expression and activity of IL-17 in cutaneous T-cell lymphomas (mycosis fungoides and Sezary syndrome).

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Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody

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

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21 January 2018

Mechanisms of adverse drug reactions to biologics

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Alternative models for carcinogenicity testing

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21 January 2018

Siglecs in innate immunity

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Developmental immunotoxicology (DIT): windows of vulnerability, immune dysfunction and safety assessment.

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Epstein-barr virus-induced lymphoma in a cardiac transplant recipient

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21 January 2018

Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells

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21 January 2018

Anti-tumor necrosis factor therapy inhibits pancreatic tumor growth and metastasis

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21 January 2018

Human herpes virus-8 and other risk factors for Kaposi's sarcoma in kidney transplant recipients. Groupe Cooperatif de Transplantation d' Ile de France (GCIF).

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Reactivation of latent Epstein-Barr virus by methotrexate: a potential contributor to methotrexate-associated lymphomas

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Cytokine release assays: current practices and future directions.

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21 January 2018

Nonclinical evaluation of GMA161--an antihuman CD16 (FcγRIII) monoclonal antibody for treatment of autoimmune disorders in CD16 transgenic mice

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Alemtuzumab in chronic lymphocytic leukemia

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A case of progressive multifocal leukoencephalopathy in a lupus patient treated with belimumab.

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Antibodies against polyethylene glycol in healthy subjects and in patients treated with PEG-conjugated agents.

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Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate

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Regulatory forum opinion piece*: tissue cross-reactivity studies: what constitutes an adequate positive control and how do we report positive staining?

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The accuracy of extended histopathology to detect immunotoxic chemicals

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Neonatal Fc receptor and its role in the absorption, distribution, metabolism and excretion of immunoglobulin G-based biotherapeutics

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Rapid regulatory T-cell response prevents cytokine storm in CD28 superagonist treated mice

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Overview of safety pharmacology

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Manipulation of lymphoid microenvironments in nonhuman primates by an inhibitor of the lymphotoxin pathway

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21 January 2018

A perspective on current and future uses of alternative models for carcinogenicity testing

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Engineered affinity proteins--generation and applications

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Species differences in the structure and function of the immune system

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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].

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Immunomodulatory effects of anti-CD4 antibody in host resistance against infections and tumors in human CD4 transgenic mice

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IL-17, IL-1beta and TNF-alpha stimulate VEGF production by dedifferentiated chondrocytes

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Antibody therapeutics: isotype and glycoform selection

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Human autoimmunity after lymphocyte depletion is caused by homeostatic T-cell proliferation

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Tolerability and safety of rituximab (MabThera).

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MHC class I A loci polymorphism and diversity in three Southeast Asian populations of cynomolgus macaque.

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21 January 2018

Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis

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Endogenous IL-17 contributes to reduced tumor growth and metastasis

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In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes

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IL-23 promotes tumour incidence and growth

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Humanized mice mount specific adaptive and innate immune responses to EBV and TSST-1.

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Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies

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Transforming growth factor beta subverts the immune system into directly promoting tumor growth through interleukin-17

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Loss of Siglec expression on T lymphocytes during human evolution

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21 January 2018

Fcgamma receptors as regulators of immune responses

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21 January 2018

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21 January 2018

Structural characterization of a human Fc fragment engineered for lack of effector functions

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21 January 2018

Control of tumor development by intratumoral cytokines

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21 January 2018

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21 January 2018

New approaches to prediction of immune responses to therapeutic proteins during preclinical development

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

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21 January 2018

Bacterial infections in cynomolgus monkeys given small molecule immunomodulatory antagonists

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21 January 2018

Antibodies to watch in 2014.

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21 January 2018

Selective disruption of lymphotoxin ligands reveals a novel set of mucosal lymph nodes and unique effects on lymph node cellular organization.

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21 January 2018

NK cell tolerance and the maternal-fetal interface

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Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology

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FcRn: the neonatal Fc receptor comes of age.

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21 January 2018

Anti-TNF therapy: safety aspects of taking the risk

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Optimizing anti-TNF treatment in inflammatory bowel disease

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21 January 2018

Preclinical safety evaluation of rhuMAbVEGF, an antiangiogenic humanized monoclonal antibody

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21 January 2018

Immunosuppression and cancer: the ciclosporin case

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21 January 2018

Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials

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Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody

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mAbs: a business perspective

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Placental transport of immunoglobulin G.

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Malignancies in the rheumatoid arthritis abatacept clinical development programme: an epidemiological assessment

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Bioanalytical method validation for macromolecules in support of pharmacokinetic studies

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Developmental toxicity testing of monoclonal antibodies: an enhanced pre- and postnatal study design option.

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21 January 2018

NIH conference. Epstein-Barr virus infections: biology, pathogenesis, and management

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Priming of protective T cell responses against virus-induced tumors in mice with human immune system components

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Immune surveillance in multiple sclerosis patients treated with natalizumab.

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Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

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Immunological relationship between the mother and the fetus

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21 January 2018

Pulmonary alveolar proteinosis, a primary immunodeficiency of impaired GM-CSF stimulation of macrophages

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Developmental immunotoxicology assessment of rituximab in cynomolgus monkeys

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21 January 2018

Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions.

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Different adaptations of IgG effector function in human and nonhuman primates and implications for therapeutic antibody treatment.

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Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia

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Monoclonal antibody first dose cytokine release syndromes-mechanisms and prediction

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21 January 2018

IFNgamma promotes papilloma development by up-regulating Th17-associated inflammation

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21 January 2018

Cyclosporine promotes the induction of thymic lymphomas in C57BL/6 mice initiated by a single dose of gamma-radiation

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21 January 2018

Genetic variation in low-dose UV-induced suppression of contact hypersensitivity and in the skin photocarcinogenesis response.

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21 January 2018

IL-17 expression by breast-cancer-associated macrophages: IL-17 promotes invasiveness of breast cancer cell lines

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21 January 2018

Juvenile animal testing in drug development--is it useful?

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7 January 2021

based on heuristic

inferred from DOI database lookup

Tumour necrosis factor and cancer

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7 January 2021

based on heuristic

inferred from DOI database lookup

Nonclinical safety, pharmacokinetics, and pharmacodynamics of atacicept

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7 January 2021

based on heuristic

inferred from DOI database lookup

Pulsed monoclonal antibody treatment and autoimmune thyroid disease in multiple sclerosis

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7 January 2021

based on heuristic

inferred from DOI database lookup

The prevalence of human papillomavirus DNA in benign keratotic skin lesions of renal transplant recipients with and without a history of skin cancer is equally high: a clinical study to assess risk factors for keratotic skin lesions and skin cancer

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7 January 2021

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inferred from DOI database lookup

Clinical immunotoxicity of therapeutic proteins

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7 January 2021

based on heuristic

inferred from DOI database lookup

Predicting cytokine storms: it's about density

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7 January 2021

based on heuristic

inferred from DOI database lookup

STP position paper: best practice guideline for the routine pathology evaluation of the immune system

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7 January 2021

based on heuristic

inferred from DOI database lookup

Antibody-mediated coengagement of FcγRIIb and B cell receptor complex suppresses humoral immunity in systemic lupus erythematosus

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Sirolimus in pediatric renal transplantation

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Comprehensive observational assessment: Ia. A systematic, quantitative procedure for assessing the behavioral and physiologic state of the mouse

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Adoptive transfer of paternal antigen-hyporesponsive T cells facilitates a Th2 bias in peripheral lymphocytes and at materno-fetal interface in murine abortion-prone matings

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Methods to engineer and identify IgG1 variants with improved FcRn binding or effector function

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Immunosuppressive drugs and HHV-8 in a patient with a renal transplant and Kaposi's sarcoma

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Enhanced photocarcinogenesis in interleukin-12-deficient mice

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

The state of the art in the development of biosimilars

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Posttransplant lymphoproliferative disorder associated with primate gamma-herpesvirus in cynomolgus monkeys used in pig-to-primate renal xenotransplantation and primate renal allotransplantation

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Aggressive CD30 large cell lymphoma after cyclosporine given for putative atopic dermatitis

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Improved pharmacokinetics of recombinant bispecific antibody molecules by fusion to human serum albumin

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Impaired tumor growth in colony-stimulating factor 1 (CSF-1)-deficient, macrophage-deficient op/op mouse: evidence for a role of CSF-1-dependent macrophages in formation of tumor stroma

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Primary observation (Irwin) test in rodents for assessing acute toxicity of a test agent and its effects on behavior and physiological function

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Increased incidence of lymphoproliferative disorder after immunosuppression with the monoclonal antibody OKT3 in cardiac-transplant recipients

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Pharmacokinetics and pharmacodynamics of a chimeric/humanized anti-CD3 monoclonal antibody, otelixizumab (TRX4), in subjects with psoriasis and with type 1 diabetes mellitus

1 reference

https://api.crossref.org/works/10.1002%2FDDR.21173

7 January 2021

based on heuristic

inferred from DOI database lookup

Identifiers

10.1002/DDR.21173

1 reference

Europe PubMed Central

31 August 2017

1 reference

Europe PubMed Central

31 August 2017

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