Detalhe da pesquisa
1.
CD19-CD28: an affinity-optimized CD28 agonist for combination with glofitamab (CD20-TCB) as off-the-shelf immunotherapy.
Blood
; 143(21): 2152-2165, 2024 May 23.
Artigo
em Inglês
| MEDLINE | ID: mdl-38437725
2.
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
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.
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
5.
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
6.
Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use.
Int J Toxicol
; 40(3): 270-284, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-33631988
7.
Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.
Regul Toxicol Pharmacol
; 94: 91-100, 2018 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-29355662
8.
Comparative assessment of immune complex-mediated hypersensitivity reactions with biotherapeutics in the non-human primate: Critical parameters, safety and lessons for future studies.
Regul Toxicol Pharmacol
; 88: 125-137, 2017 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-28624430
9.
Non-clinical Safety Evaluation of Biotherapeutics - Challenges, Opportunities and new Insights.
Regul Toxicol Pharmacol
; 80S: S1-S14, 2016 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-27578450
10.
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
11.
New challenges and opportunities in nonclinical safety testing of biologics.
Regul Toxicol Pharmacol
; 69(2): 226-33, 2014 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-24755365
12.
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
13.
Development of a nonhuman primate challenge model to evaluate CD8+ T cell responses to an adenovirus-based vaccine expressing SIV proteins upon repeat-dose treatment with checkpoint inhibitors.
MAbs
; 14(1): 1979447, 2022.
Artigo
em Inglês
| MEDLINE | ID: mdl-34923919
14.
Challenges of non-clinical safety testing for biologics: A Report of the 9th BioSafe European Annual General Membership Meeting.
MAbs
; 13(1): 1938796, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34241561
15.
Blinded by the light: retinal phototoxicity in the context of safety studies.
Toxicol Pathol
; 41(6): 813-25, 2013 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-23271306
16.
Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy.
Mol Cancer Ther
; 17(7): 1464-1474, 2018 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-29654069
17.
Distribution of FcRn Across Species and Tissues.
J Histochem Cytochem
; 65(6): 321-333, 2017 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-28402755
18.
Allelic variants of drug metabolizing enzymes as risk factors in psoriasis.
J Invest Dermatol
; 120(5): 765-70, 2003 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-12713578
19.
Pharmacological control of platelet-leukocyte interactions by the human anti-P-selectin antibody inclacumab--preclinical and clinical studies.
Thromb Res
; 131(5): 401-10, 2013 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-23522853
20.
Current challenges and opportunities in nonclinical safety testing of biologics.
Drug Discov Today
; 18(23-24): 1138-43, 2013 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-23942260