(Q37379764)

20 August 2017

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title

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

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20 August 2017

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P Y Muller

1

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20 August 2017

F R Brennan

series ordinal

2

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20 August 2017

language of work or name

English

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publication date

28 January 2009

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Clinical Pharmacology & Therapeutics

20 August 2017

published in

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20 August 2017

volume

85

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20 August 2017

issue

3

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20 August 2017

page(s)

247-258

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CTLA-4: negative regulator of the immune response and a target for cancer therapy

20 August 2017

cites work

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

Immunostimulatory monoclonal antibodies for cancer therapy

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The effects of antibody treatment on regulatory CD4(+)CD25(+) T cells

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Preclinical and clinical safety of monoclonal antibodies

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

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

21 January 2018

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

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Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics

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Loss of Siglec expression on T lymphocytes during human evolution

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Siglecs in innate immunity

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Antibody therapeutics: isotype and glycoform selection

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Studies of monkey complement: measurement of cynomolgus monkey CH50, ACH50, C4, C2 and C3.

21 January 2018

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc

21 January 2018

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Toxicity as a result of immunostimulation by biologics

21 January 2018

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High-risk molecules or insufficient scientific data?

21 January 2018

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A phase II study of irinotecan alternated with a weekly schedule of high-dose leucovorin and 48-hour 5-fluorouracil infusion in patients with metastatic colorectal cancer

21 January 2018

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FcRn: the neonatal Fc receptor comes of age.

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Elimination mechanisms of therapeutic monoclonal antibodies

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On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development

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Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies

21 January 2018

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CD28 superagonists: what makes the difference in humans?

21 January 2018

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Innovative early development regulatory approaches: expIND, expCTA, microdosing

21 January 2018

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A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs

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21 January 2018

Lessons from TGN1412.

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Toward experimental assessment of receptor occupancy: TGN1412 revisited

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Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis

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7 January 2021

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

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7 January 2021

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

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TGN1412—a regulator's perspective

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

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

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7 January 2021

Complement activation is responsible for acute toxicities in rhesus monkeys treated with a phosphorothioate oligodeoxynucleotide

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

Humanized IgG1 and IgG4 anti-CD4 monoclonal antibodies: effects on lymphocytes in the blood, lymph nodes, and renal allografts in cynomolgus monkeys

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7 January 2021

https://api.crossref.org/works/10.1038%2FCLPT.2008.273

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7 January 2021

"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

Idiotypic-anti-idiotypic complexes and their in vivo metabolism

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug

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https://api.crossref.org/works/10.1038%2FCLPT.2008.273

7 January 2021

Identifiers

DOI

10.1038/CLPT.2008.273

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20 August 2017

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