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1.
Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial.
Crit Care Med
; 50(3): 398-409, 2022 03 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34612846
2.
Nonclinical toxicology development of a novel antibody antibiotic conjugate for treating invasive Staphylococcus Aureus infections.
Toxicol Appl Pharmacol
; 435: 115811, 2022 01 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-34896194
3.
Matrix and Sampling Effects on Quantification of Protein Biomarkers of Drug-Induced Liver Injury.
J Proteome Res
; 20(11): 4985-4994, 2021 11 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-34554759
4.
A Prognostic Model of Persistent Bacteremia and Mortality in Complicated Staphylococcus aureus Bloodstream Infection.
Clin Infect Dis
; 68(9): 1502-1511, 2019 04 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-30165412
5.
A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti-Staphylococcus aureus Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers.
Antimicrob Agents Chemother
; 63(6)2019 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-30910894
6.
Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations.
AAPS J
; 25(5): 82, 2023 08 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-37594571
7.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Bioanalysis
; 15(14): 773-814, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-37526071
8.
Safety, Tolerability, and Pharmacokinetics of High-Volume Subcutaneous Crenezumab, With and Without Recombinant Human Hyaluronidase in Healthy Volunteers.
Clin Pharmacol Ther
; 110(5): 1337-1348, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34347883
9.
An Anti-CD22-seco-CBI-Dimer Antibody-Drug Conjugate (ADC) for the Treatment of Non-Hodgkin Lymphoma That Provides a Longer Duration of Response than Auristatin-Based ADCs in Preclinical Models.
Mol Cancer Ther
; 20(2): 340-346, 2021 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-33273056
10.
Risk stratification biomarkers for Staphylococcus aureus bacteraemia.
Clin Transl Immunology
; 9(2): e1110, 2020.
Artículo
en Inglés
| MEDLINE | ID: mdl-32082571
11.
Safety, Tolerability, and Pharmacokinetics of Crenezumab in Patients with Mild-to-Moderate Alzheimer's Disease Treated with Escalating Doses for up to 133 Weeks.
J Alzheimers Dis
; 76(3): 967-979, 2020.
Artículo
en Inglés
| MEDLINE | ID: mdl-32568196
12.
A Phase I Study of DLYE5953A, an Anti-LY6E Antibody Covalently Linked to Monomethyl Auristatin E, in Patients with Refractory Solid Tumors.
Clin Cancer Res
; 26(21): 5588-5597, 2020 11 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-32694157
13.
Immunogenicity of antibody-drug conjugates: observations across 8 molecules in 11 clinical trials.
Bioanalysis
; 11(17): 1555-1568, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31208199
14.
Preclinical and translational pharmacokinetics of a novel THIOMAB™ antibody-antibiotic conjugate against Staphylococcus aureus.
MAbs
; 11(6): 1162-1174, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-31219754
15.
Prognostic Power of Pathogen Cell-Free DNA in Staphylococcus aureus Bacteremia.
Open Forum Infect Dis
; 6(4): ofz126, 2019 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-31041341
16.
Minimal physiologically-based pharmacokinetic modeling of DSTA4637A, A novel THIOMAB™ antibody antibiotic conjugate against Staphylococcus aureus, in a mouse model.
MAbs
; 10(7): 1131-1143, 2018 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-30081725
17.
Preclinical pharmacokinetics and pharmacodynamics of DCLL9718A: An antibody-drug conjugate for the treatment of acute myeloid leukemia.
MAbs
; 10(8): 1312-1321, 2018.
Artículo
en Inglés
| MEDLINE | ID: mdl-30183491
18.
Development and Translational Application of an Integrated, Mechanistic Model of Antibody-Drug Conjugate Pharmacokinetics.
AAPS J
; 19(1): 130-140, 2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27679517
19.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 9(24): 1967-1996, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205064
20.
Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development.
J Immunol Res
; 2016: 2618575, 2016.
Artículo
en Inglés
| MEDLINE | ID: mdl-27092313