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1.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
2.
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Bioanalysis
; 15(15): 861-903, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-37584363
3.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578991
4.
Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: follow-up from months 12-24 in a Phase III randomized study of healthy women aged 18-45 years.
Hum Vaccin
; 7(12): 1343-58, 2011 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22048173
5.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33533276
6.
Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years.
Hum Vaccin
; 5(10): 705-19, 2009 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-19684472
7.
Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine.
Hum Vaccin
; 4(6): 425-34, 2008.
Artículo
en Inglés
| MEDLINE | ID: mdl-18948732
8.
Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: follow-up through Month 48 in a Phase III randomized study.
Hum Vaccin Immunother
; 10(12): 3455-65, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25483700
9.
Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials.
Vaccine
; 32(29): 3694-705, 2014 Jun 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-24674663
10.
Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial.
Am J Trop Med Hyg
; 91(1): 119-28, 2014 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-24865677
11.
A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults.
Am J Trop Med Hyg
; 88(1): 73-88, 2013 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-23208878
12.
Evaluation of systemic and mucosal anti-HPV16 and anti-HPV18 antibody responses from vaccinated women.
Vaccine
; 26(29-30): 3608-16, 2008 Jul 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-18541349
13.
Comparative evaluation of three assays for measurement of dengue virus neutralizing antibodies.
Am J Trop Med Hyg
; 79(1): 115-22, 2008 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-18606774
14.
Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only.
Vaccine
; 24(33-34): 5937-49, 2006 Aug 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-16828940
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