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1.
Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines.
Aesthet Surg J
; 43(10): 1189-1193, 2023 09 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-37051886
2.
Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies.
BMC Endocr Disord
; 21(1): 129, 2021 Jun 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-34174848
3.
Development and validation of a noncompetitive electrochemiluminescence-based immunoassay (ECLIA) for specific determination of insulin lispro (Humalog®) in human serum to support pharmacokinetic assessments.
J Immunoassay Immunochem
; 40(3): 314-327, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-30924380
4.
Clinical Immunogenicity of DaxibotulinumtoxinA for Injection in Glabellar Lines: Pooled Data from the SAKURA Phase 3 Trials.
Toxins (Basel)
; 15(1)2023 01 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-36668880
5.
Noncompetitive immunoassay optimized for pharmacokinetic assessments of biologically active efruxifermin.
J Pharm Biomed Anal
; 232: 115402, 2023 Aug 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-37141854
6.
Critical reagent inventory management system and web portal specifically optimized for supporting external clients.
Bioanalysis
; 14(12): 869-879, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35904158
7.
Sensitive assay design for detection of anti-drug antibodies to biotherapeutics that lack an immunoglobulin Fc domain.
Sci Rep
; 11(1): 15467, 2021 07 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-34326436
8.
An Integrated Analysis of Dostarlimab Immunogenicity.
AAPS J
; 23(5): 96, 2021 07 29.
Artículo
en Inglés
| MEDLINE | ID: mdl-34324079
9.
FN3-based monobodies selective for the receptor binding domain of the SARS-CoV-2 spike protein.
N Biotechnol
; 62: 79-85, 2021 May 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-33556628
10.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34853961
11.
Purification, characterization and identification of rat brain cytosolic tyrosine transaminase as glutamine Transaminase-K.
Neurochem Int
; 133: 104653, 2020 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31874188
12.
Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.
AAPS J
; 22(1): 7, 2019 12 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31792633
13.
Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kappaB ligand.
J Pharm Biomed Anal
; 48(5): 1282-9, 2008 Dec 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-18977625
14.
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.
J Pharm Biomed Anal
; 48(5): 1267-81, 2008 Dec 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-18993008
15.
Recommendations for Systematic Statistical Computation of Immunogenicity Cut Points.
AAPS J
; 19(5): 1487-1498, 2017 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-28733862
16.
Development, validation, and implementation of a multiplex immunoassay for the simultaneous determination of five cytokines in human serum.
J Pharm Biomed Anal
; 36(5): 1037-44, 2005 Jan 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-15620530
17.
Are Lessons Learned in Setting Cut Points for Detection of Anti-Drug Antibodies Also Useful in Serology Assays for Robust Detection of SARS-CoV-2 Reactive Antibodies?
AAPS J
; 22(6): 127, 2020 10 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-33025311
18.
Using DTA and DTAARRAY variables and programming in WinNonlin ASCII models to streamline user-defined calculation and data analysis.
AAPS J
; 17(2): 474-8, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25583216
19.
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.
AAPS J
; 17(4): 1019-24, 2015 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-25921938
20.
Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development.
Bioanalysis
; 7(2): 229-42, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-25587839