Detalhe da pesquisa
1.
Integration of Consortia Recommendations for Justification of Animal Use Within Current and Future Drug Development Paradigms.
Int J Toxicol
; 38(4): 319-325, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31220983
2.
Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges.
Regul Toxicol Pharmacol
; 98: 98-107, 2018 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-30026135
3.
Translational immunotoxicology of immunomodulatory monoclonal antibodies.
Drug Discov Today Technol
; 21-22: 85-93, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27978992
4.
Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies.
Regul Toxicol Pharmacol
; 73(1): 265-75, 2015 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-26219199
5.
Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases.
Drug Dev Res
; 75(3): 115-61, 2014 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-24782266
6.
Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC).
Clin Pharmacol Ther
; 2024 Jun 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-38847597
7.
Current nonclinical approaches for immune assessments of immuno-oncology biotherapeutics.
Drug Discov Today
; 28(2): 103440, 2023 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-36375739
8.
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Clin Pharmacol Ther
; 109(6): 1395-1415, 2021 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-32757299
9.
Generation of two high affinity anti-mouse FcRn antibodies: Inhibition of IgG recycling in wild type mice and effect in a mouse model of immune thrombocytopenia.
Int Immunopharmacol
; 66: 362-365, 2019 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-30529500
10.
Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.
MAbs
; 10(1): 1-17, 2018 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28991509
11.
Engineered hexavalent Fc proteins with enhanced Fc-gamma receptor avidity provide insights into immune-complex interactions.
Commun Biol
; 1: 146, 2018.
Artigo
em Inglês
| MEDLINE | ID: mdl-30272022
12.
Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration.
MAbs
; 10(7): 1111-1130, 2018 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-30130439
13.
In vitro assays supporting the safety assessment of immunomodulatory monoclonal antibodies.
Toxicol In Vitro
; 45(Pt 3): 296-308, 2017 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-28263892
14.
Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges.
Mol Biotechnol
; 27(1): 59-74, 2004 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-15122047
15.
Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies.
MAbs
; 2(3): 233-55, 2010.
Artigo
em Inglês
| MEDLINE | ID: mdl-20421713
16.
The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies.
Curr Opin Biotechnol
; 20(6): 722-9, 2009 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-19896825
17.
Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies.
Vaccine
; 23(24): 3210-22, 2005 May 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-15837222
18.
Optimization of Salmonella enterica serovar typhi DeltaaroC DeltassaV derivatives as vehicles for delivering heterologous antigens by chromosomal integration and in vivo inducible promoters.
Infect Immun
; 73(1): 362-8, 2005 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-15618173
19.
A chimaeric plant virus vaccine protects mice against a bacterial infection.
Microbiology (Reading)
; 145 ( Pt 8): 2061-2067, 1999 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-10463172
20.
Salmonella typhi and S typhimurium derivatives harbouring deletions in aromatic biosynthesis and Salmonella Pathogenicity Island-2 (SPI-2) genes as vaccines and vectors.
Vaccine
; 21(5-6): 538-48, 2003 Jan 17.
Artigo
em Inglês
| MEDLINE | ID: mdl-12531654