Detalhe da pesquisa
1.
Characterizing the Pharmacokinetics and Biodistribution of Therapeutic Proteins: An Industry White Paper.
Drug Metab Dispos
; 50(6): 858-866, 2022 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-35149542
2.
Absorption, Distribution, Metabolism, and Excretion of Therapeutic Proteins: Current Industry Practices and Future Perspectives.
Drug Metab Dispos
; 50(6): 837-845, 2022 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-35149541
3.
The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis.
Br J Clin Pharmacol
; 86(12): 2507-2518, 2020 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-32415720
4.
First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis.
Eur J Clin Pharmacol
; 72(11): 1303-1310, 2016 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-27515978
5.
Clinical Pharmacology Perspective on Development of Adeno-Associated Virus Vector-Based Retina Gene Therapy.
Clin Pharmacol Ther
; 2024 Mar 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-38450707
6.
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Clin Pharmacol Ther
; 115(2): 188-200, 2024 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-37983584
7.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Mol Ther Methods Clin Dev
; 32(1): 101217, 2024 Mar 14.
Artigo
em Inglês
| MEDLINE | ID: mdl-38496304
8.
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance.
AAPS J
; 25(6): 93, 2023 09 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-37770755
9.
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Clin Pharmacol Ther
; 114(3): 530-557, 2023 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-37393588
10.
A Phase 1 First-in-Human Pharmacokinetic and Pharmacodynamic Study of JNJ-64264681, a Covalent Inhibitor of Bruton's Tyrosine Kinase.
Clin Pharmacol Drug Dev
; 12(6): 611-624, 2023 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-37125450
11.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J
; 25(5): 78, 2023 07 31.
Artigo
em Inglês
| MEDLINE | ID: mdl-37523051
12.
Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs).
AAPS J
; 24(5): 93, 2022 08 26.
Artigo
em Inglês
| MEDLINE | ID: mdl-36028587
13.
Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma.
Target Oncol
; 17(4): 433-439, 2022 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-35749004
14.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Mol Ther Methods Clin Dev
; 26: 471-494, 2022 Sep 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-36092368
15.
Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T products in clinical studies.
Bioanalysis
; 13(2): 115-128, 2021 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-33356555
16.
Bifunctional molecules targeting SARS-CoV-2 spike and the polymeric Ig receptor display neutralization activity and mucosal enrichment.
MAbs
; 13(1): 1987180, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34693867
17.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33533276
18.
Application of multiplexed pharmacokinetic immunoassay to quantify in vivo drug forms and coadministered biologics.
Bioanalysis
; 11(24): 2251-2268, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31845605
19.
Analysis of regulatory guidance on antidrug antibody testing for therapeutic protein products.
Bioanalysis
; 11(24): 2283-2296, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31845602
20.
Approaches to improve drug tolerance and target tolerance in the assessment of neutralizing anti-drug antibodies.
Bioanalysis
; 11(22): 2061-2074, 2019 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-31829737