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

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About: Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies Goto Sponge NotDistinct Permalink

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scientific article published on 28 January 2009

Attributes	Values
rdf:type	Item
description	videnskabelig artikel (da) article científic (ca) articolo scientifico (it) artigo científico (pt) bilimsel makale (tr) vedecký článok (sk) vetenskaplig artikel (sv) vědecký článek (cs) wetenschappelijk artikel (nl) wissenschaftlicher Artikel (de) научни чланак (sr) article scientifique (fr) artículu científicu espublizáu en 2009 (ast) наукова стаття, опублікована в січні 2009 (uk) scientific article published on 28 January 2009 (en) مقالة علمية نشرت في 28 يناير 2009 (ar)
publication date	wds:Q37379764-208A4EFC-4FCA-437B-AB93-7AD3B352381D
publication date	2009-01-28 00:00:00Z (xsd:dateTime)
language of work or name	wds:Q37379764-9C78C9F0-0A4A-4B16-B53A-813720198F2B
language of work or name	English
cites work	wds:Q37379764-0EBD122E-74FF-4B20-B308-F62363033CFD wds:Q37379764-15768FD5-03E2-45B3-BBDF-F00F7992CB7E wds:Q37379764-1E7F3EDB-F338-4C39-9B9F-235AF9BF62AB wds:Q37379764-2BA8C936-A0DD-4668-B014-7C10D9F73716 wds:Q37379764-2E27525D-E306-49CE-9672-F06322C4AD9A wds:Q37379764-33E0FCCB-9DF2-424F-92B5-A6E705A67211 wds:Q37379764-3C98A8CF-D1F6-4E24-B7D5-311A4869E06A wds:Q37379764-41DE8782-50D6-4C02-AD41-6979D96B09A8 wds:Q37379764-48CD0A4B-97DC-4B1E-9577-FDB80B9D6BA0 wds:Q37379764-4AF84DF4-8175-402A-9396-CF0931C04927 wds:Q37379764-4CE57EBB-835D-4614-9D8F-CA0A28F93C6F wds:Q37379764-5ACC3ED8-CD0E-406F-811D-49AD21D7721F wds:Q37379764-646416F9-0A73-481B-8416-2AD54779964B wds:Q37379764-6C49147C-A78E-4603-BD92-461604E5759B wds:Q37379764-6F395D6A-64E2-47EF-9F4D-8EBAA858C2EE wds:Q37379764-703AEF62-520A-43D0-BCDF-F73003A6468C wds:Q37379764-72FDECF1-DDBB-4713-8D7B-6BB2D6AA53F9 wds:Q37379764-747BF10A-D069-42EA-9965-3185946032B9 wds:Q37379764-76D4ED4A-E30D-45F0-82C2-A654F1396BE8 wds:Q37379764-7F6E96BB-492F-4CB1-8786-D3A0E964D435 wds:Q37379764-80855AFC-46F5-4370-BC36-F547A5270818 wds:Q37379764-816978FE-4563-4FF9-ACF0-193C5992A7B5 wds:Q37379764-866B4F0B-0CAC-456D-955B-B441BA711ED2 wds:Q37379764-90733679-3288-42AB-84F3-F2EF3D79C52B wds:Q37379764-96184667-1993-4EC8-85C4-8FD1E93BF240 wds:Q37379764-98F4C9F0-4F57-4418-A003-65825F599BE5 wds:Q37379764-AB8050F8-7D43-4EAF-89FF-B41A82BDE898 wds:Q37379764-C0EC1C67-ED1A-4C46-89A0-5DD122EA43DA wds:Q37379764-D58CA814-7416-42D9-92A9-DB4552AEDE13 wds:Q37379764-D620ADE4-3288-4F2A-9CF9-6B1DF85B3906 wds:Q37379764-DAED2201-085A-4AF1-A930-E05DC3C4387D wds:Q37379764-F2345E30-C97D-4A96-8D66-F690C6E0184B wds:Q37379764-F3C2AC8D-700C-42BE-8EDF-68D4BD033DB4 wds:Q37379764-F769B0AF-7C68-421D-BA47-72F6167F81B8 wds:Q37379764-F8134BDA-8E40-4789-A935-55CB7924568F wds:Q37379764-FE3EB626-EDA4-4F1C-9CAD-251AE7E174DF
cites work	Immunostimulatory monoclonal antibodies for cancer therapy Elimination mechanisms of therapeutic monoclonal antibodies FcRn: the neonatal Fc receptor comes of age. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412 Antibody therapeutics: isotype and glycoform selection Preclinical and clinical safety of monoclonal antibodies Complement activation is responsible for acute toxicities in rhesus monkeys treated with a phosphorothioate oligodeoxynucleotide "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development Siglecs in innate immunity Mapping of the C1q binding site on rituxan, a chimeric antibody with a human IgG1 Fc Loss of Siglec expression on T lymphocytes during human evolution Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs TGN1412—a regulator's perspective Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products Humanized IgG1 and IgG4 anti-CD4 monoclonal antibodies: effects on lymphocytes in the blood, lymph nodes, and renal allografts in cynomolgus monkeys IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics CD28 superagonists: what makes the difference in humans? Lessons from TGN1412. Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody Innovative early development regulatory approaches: expIND, expCTA, microdosing Toxicity as a result of immunostimulation by biologics STP position paper: best practice guideline for the routine pathology evaluation of the immune system CTLA-4: negative regulator of the immune response and a target for cancer therapy Studies of monkey complement: measurement of cynomolgus monkey CH50, ACH50, C4, C2 and C3. Toward experimental assessment of receptor occupancy: TGN1412 revisited Idiotypic-anti-idiotypic complexes and their in vivo metabolism 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 High-risk molecules or insufficient scientific data? The effects of antibody treatment on regulatory CD4(+)CD25(+) T cells T-cell costimulation
author name string	wds:Q37379764-421B863F-A680-408E-A937-D0F09BC1040F wds:Q37379764-67C43400-2F4E-47A9-A3C7-BEB5883DDD95
author name string	P Y Muller F R Brennan
rdfs:label	Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies (en) Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies (nl) Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies (ast)

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