Detalles de la búsqueda
1.
Translation of nonclinical to clinical safety findings for 27 biotherapeutics.
Toxicol Appl Pharmacol
; 484: 116854, 2024 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-38346540
2.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-36592682
3.
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Regul Toxicol Pharmacol
; 138: 105339, 2023 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-36649820
4.
Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules - A survey of industry 2008-2019.
Regul Toxicol Pharmacol
; 121: 104872, 2021 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-33485926
5.
Comparative nonclinical assessments of the biosimilar PF-06410293 and originator adalimumab.
Regul Toxicol Pharmacol
; 112: 104587, 2020 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-32006671
6.
Nonclinical assessments of the potential biosimilar PF-06439535 and bevacizumab.
Regul Toxicol Pharmacol
; 95: 236-243, 2018 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-29574193
7.
A Synopsis of the "Influence of Epigenetics, Genetics, and Immunology" Session Part A at the 35th Annual Society of Toxicologic Pathology Symposium.
Toxicol Pathol
; 45(1): 114-118, 2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27708198
8.
Nonproliferative and Proliferative Lesions of the Gastrointestinal Tract, Pancreas and Salivary Glands of the Rat and Mouse.
J Toxicol Pathol
; 29(1 Suppl): 1S-125S, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-26973378
9.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.
Toxicol Pathol
; 43(7): 915-34, 2015 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25722122
10.
Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.
Toxicol Pathol
; 43(7): 935-44, 2015 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-25717082
11.
Immunogenicity/hypersensitivity of biologics.
Toxicol Pathol
; 42(1): 293-300, 2014 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-24240973
12.
Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®).
Toxicol Pathol
; 42(7): 1069-81, 2014 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-24604381
13.
"Candidatus Mycoplasma haemomacaque" and Bartonella quintana bacteremia in cynomolgus monkeys.
J Clin Microbiol
; 51(5): 1408-11, 2013 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-23408694
14.
Regulatory forum opinion piece: differences between protein-based biologic products (biotherapeutics) and chemical entities (small molecules) of relevance to the toxicologic pathologist.
Toxicol Pathol
; 41(1): 128-36, 2013 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-22744226
15.
Cytosolic phospholipase A2α blockade abrogates disease during the tissue-damage effector phase of experimental autoimmune encephalomyelitis by its action on APCs.
J Immunol
; 187(4): 1986-97, 2011 Aug 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-21746963
16.
Reproductive performance and early postnatal development in interleukin (IL)-13-deficient mice.
Birth Defects Res B Dev Reprod Toxicol
; 95(5): 346-53, 2012 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-22930549
17.
Cytosolic phospholipase A2 alpha-deficient mice are resistant to experimental autoimmune encephalomyelitis.
J Exp Med
; 202(6): 841-51, 2005 Sep 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-16172261
18.
Survey results on the use of the tissue cross-reactivity immunohistochemistry assay.
Regul Toxicol Pharmacol
; 59(3): 493-502, 2011 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-20951178
19.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-32757299
20.
Correlation of pharmacodynamic activity, pharmacokinetics, and anti-product antibody responses to anti-IL-21R antibody therapeutics following IV administration to cynomolgus monkeys.
J Transl Med
; 8: 41, 2010 Apr 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-20420683