Detalhe da pesquisa
1.
Precision Dosing: A Clinical and Public Health Imperative.
JAMA
; 325(15): 1505-1506, 2021 Apr 20.
Artigo
em Inglês
| MEDLINE | ID: mdl-33760028
2.
2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Bioanalysis
; 16(7): 77-119, 2024 Apr.
Artigo
em Inglês
| MEDLINE | ID: mdl-38389403
3.
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
AAPS J
; 25(4): 54, 2023 05 26.
Artigo
em Inglês
| MEDLINE | ID: mdl-37231199
4.
FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Clin Cancer Res
; 29(3): 508-512, 2023 02 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-36112541
5.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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.
Artigo
em Inglês
| MEDLINE | ID: mdl-37526071
6.
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578991
7.
Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.
Clin Pharmacol Ther
; 109(3): 697-704, 2021 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-32895941
8.
A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.
Clin Pharmacol Ther
; 109(1): 123-130, 2021 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-33022770
9.
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.
Ther Innov Regul Sci
; 54(6): 1363-1371, 2020 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-33258100
10.
Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments.
Clin Pharmacol Ther
; 113(2): 221-225, 2023 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-35253213
11.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 10(24): 1973-2001, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488726
12.
SIK2 Restricts Autophagic Flux To Support Triple-Negative Breast Cancer Survival.
Mol Cell Biol
; 36(24): 3048-3057, 2016 12 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-27697861
13.
Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting.
Clin Pharmacol Ther
; 109(1): 25-28, 2021 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-32663324
14.
Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use.
Clin Pharmacol Ther
; 108(4): 710-715, 2020 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-32430963
15.
Comprehensive functional characterization of cancer-testis antigens defines obligate participation in multiple hallmarks of cancer.
Nat Commun
; 6: 8840, 2015 Nov 16.
Artigo
em Inglês
| MEDLINE | ID: mdl-26567849
16.
Proceedings of a Workshop: US Food and Drug Administration-International Society of Pharmacometrics Model-Informed Drug Development in Oncology.
Clin Pharmacol Ther
; 106(1): 81-83, 2019 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-30951201
17.
The Role of Public-Private Partnerships in Catalyzing the Critical Path.
Clin Transl Sci
; 10(6): 431-442, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-28776943
18.
Multiple cancer testis antigens function to support tumor cell mitotic fidelity.
Mol Cell Biol
; 32(20): 4131-40, 2012 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-22869527
19.
Thin-walled microvessels in human coronary atherosclerotic plaques show incomplete endothelial junctions relevance of compromised structural integrity for intraplaque microvascular leakage.
J Am Coll Cardiol
; 53(17): 1517-27, 2009 Apr 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-19389562