Detalhe da pesquisa
1.
FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Regul Toxicol Pharmacol
; 138: 105327, 2023 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-36586472
2.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Regul Toxicol Pharmacol
; 138: 105339, 2023 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-36649820
3.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Regul Toxicol Pharmacol
; 138: 105329, 2023 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-36592682
4.
Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies.
Regul Toxicol Pharmacol
; 119: 104825, 2021 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-33220389
5.
Nonclinical safety of tildrakizumab, a humanized anti-IL-23p19 monoclonal antibody, in nonhuman primates.
Regul Toxicol Pharmacol
; 108: 104476, 2019 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-31536773
6.
An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors.
Birth Defects Res B Dev Reprod Toxicol
; 107(2): 108-19, 2016 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-27062127
7.
Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis.
Toxicol Sci
; 2024 Apr 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-38588579
8.
A T-cell-dependent antibody response study using a murine surrogate anti-PD-1 monoclonal antibody as an alternative to a non-human primate model.
J Immunotoxicol
; 17(1): 175-185, 2020 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-33078980
9.
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab.
Mol Cancer Ther
; 19(6): 1298-1307, 2020 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-32229606
10.
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
Regul Toxicol Pharmacol
; 54(2): 164-82, 2009 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-19345250
11.
Drug safety Africa: An overview of safety pharmacology & toxicology in South Africa.
J Pharmacol Toxicol Methods
; 98: 106579, 2019.
Artigo
em Inglês
| MEDLINE | ID: mdl-31085319
12.
Cancer Immunotherapy: Factors Important for the Evaluation of Safety in Nonclinical Studies.
AAPS J
; 20(2): 28, 2018 02 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-29417397
13.
Characterization of MK-4166, a Clinical Agonistic Antibody That Targets Human GITR and Inhibits the Generation and Suppressive Effects of T Regulatory Cells.
Cancer Res
; 77(16): 4378-4388, 2017 08 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-28611044
14.
The immunogenicity of therapeutic cytokines.
Curr Opin Mol Ther
; 5(2): 167-71, 2003 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-12772507
15.
Primary antibody response to keyhole limpet hemocyanin in rat as a model for immunotoxicity evaluation.
Toxicology
; 197(1): 23-35, 2004 Apr 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-15003331
16.
Adequate immunotoxicity testing in drug development.
Toxicol Lett
; 149(1-3): 115-22, 2004 Apr 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-15093256
17.
Assessing immunotoxicity of pharmaceuticals: the need for enhanced testing.
Fundam Clin Pharmacol
; 19(3): 323-8; author reply 329-30, 2005 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-15910655
18.
The T-dependent antibody response to keyhole limpet hemocyanin in rodents.
Methods Mol Biol
; 598: 159-71, 2010.
Artigo
em Inglês
| MEDLINE | ID: mdl-19967512
19.
Summary of a workshop on nonclinical and clinical immunotoxicity assessment of immunomodulatory drugs.
J Immunotoxicol
; 6(1): 1-10, 2009 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-19519157
20.
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].
J Immunotoxicol
; 4(2): 143-7, 2007 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-18958722