Detalhe da pesquisa
1.
Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study.
J Am Acad Dermatol
; 82(2): 377-388, 2020 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-31374300
2.
Mechanistic investigation of the preclinical pharmacokinetics and interspecies scaling of PF-05231023, a fibroblast growth factor 21-antibody protein conjugate.
Drug Metab Dispos
; 43(6): 803-11, 2015 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-25805881
3.
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy.
AAPS J
; 24(4): 76, 2022 06 21.
Artigo
em Inglês
| MEDLINE | ID: mdl-35725847
4.
Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay.
AAPS J
; 24(4): 78, 2022 07 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-35778641
5.
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
6.
REGN1908-1909 monoclonal antibodies block Fel d 1 in cat allergic subjects: Translational pharmacokinetics and pharmacodynamics.
Clin Transl Sci
; 14(6): 2440-2449, 2021 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-34437752
7.
The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis.
Clin Pharmacol Ther
; 110(5): 1318-1328, 2021 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-34270797
8.
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
9.
Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti-Activin A): Results From a First-in-Human Phase 1 Study.
J Clin Pharmacol
; 60(11): 1424-1431, 2020 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-32557665
10.
Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial.
JAMA Dermatol
; 156(2): 131-143, 2020 02 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-31876900
11.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Bioanalysis
; 11(24): 2207-2244, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31820675
12.
Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies.
AAPS J
; 19(6): 1564-1575, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-29063411
13.
Pre-existing Antibody: Biotherapeutic Modality-Based Review.
AAPS J
; 18(2): 311-20, 2016 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-26821802
14.
Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies.
J Pharm Biomed Anal
; 39(3-4): 364-75, 2005 Sep 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-15963677
15.
Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.
Bioanalysis
; 7(11): 1325-35, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26110705
16.
2012 AAPS National Biotech Conference Open Forum: a perspective on the current state of immunogenicity prediction and risk management.
AAPS J
; 15(4): 1155-9, 2013 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-23990501
17.
Pre-existing biotherapeutic-reactive antibodies: survey results within the American Association of Pharmaceutical Scientists.
AAPS J
; 15(3): 852-5, 2013 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-23620231
18.
Current advances in delivery of biotherapeutics across the blood-brain barrier.
Curr Drug Discov Technol
; 8(2): 87-101, 2011 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-21513485