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1.
Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography-Tandem Mass Spectrometry: Current State and Future Vision.
Clin Chem
; 66(2): 282-301, 2020 02 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-32040572
2.
A novel rizatriptan oral gel formulation: Bioavailability and bioequivalence.
Int J Clin Pharmacol Ther
; 58(10): 583-594, 2020 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-32716291
3.
Elimination of isobaric interference and signal-to-noise ratio enhancement using on-line mobile phase filtration in liquid chromatography/tandem mass spectrometry.
Rapid Commun Mass Spectrom
; 28(8): 886-92, 2014 Apr 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-24623692
4.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-38389403
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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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.
Artículo
en Inglés
| MEDLINE | ID: mdl-37526071
6.
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
7.
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 15(16): 955-1016, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-37650500
8.
Dried blood spot on-card derivatization: an alternative form of sample handling to overcome the instability of thiorphan in biological matrix.
Biomed Chromatogr
; 26(12): 1617-24, 2012 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-22511292
9.
Biomarker Assay Validation by Mass Spectrometry.
AAPS J
; 24(3): 66, 2022 05 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-35534647
10.
Recommendations on qPCR/ddPCR assay validation by GCC.
Bioanalysis
; 14(12): 853-863, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35703321
11.
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Bioanalysis
; 14(10): 627-692, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578974
12.
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
13.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578993
14.
Recommendations on ELISpot assay validation by the GCC.
Bioanalysis
; 14(4): 187-193, 2022 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-35135309
15.
Pre-cut dried blood spot (PCDBS): an alternative to dried blood spot (DBS) technique to overcome hematocrit impact.
Rapid Commun Mass Spectrom
; 25(19): 2951-8, 2011 Oct 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-21913274
16.
Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Bioanalysis
; 13(8): 609-619, 2021 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-33847160
17.
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Bioanalysis
; 13(4): 203-238, 2021 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-33470871
18.
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
19.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
20.
Estimation of an Appropriate Dose of Trazodone for Pediatric Insomnia and the Potential for a Trazodone-Atomoxetine Interaction.
CPT Pharmacometrics Syst Pharmacol
; 9(2): 77-86, 2020 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-31808613