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Published in The AAPS journal (02.09.2023)
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A sensitive LC-MS/MS assay for the determination of dextromethorphan and metabolites in human urine—application for drug interaction studies assessing potential CYP3A and CYP2D6 inhibition
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Published in The AAPS journal (08.07.2023)
Published in The AAPS journal (08.07.2023)
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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
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Published in Bioanalysis (01.08.2023)
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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)
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Published in Bioanalysis (01.04.2024)
Published in Bioanalysis (01.04.2024)
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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunoge
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Published in Bioanalysis (02.05.2024)
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Safety and pharmacology of a single intravenous dose of ponezumab in subjects with mild-to-moderate Alzheimer disease: a phase I, randomized, placebo-controlled, double-blind, dose-escalation study
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Published in Clinical neuropharmacology (01.01.2013)
Published in Clinical neuropharmacology (01.01.2013)
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Safety and pharmacology of ponezumab (PF-04360365) after a single 10-minute intravenous infusion in subjects with mild to moderate Alzheimer disease
Burstein, Aaron H, Zhao, Qinying, Ross, Joel, Styren, Scot, Landen, Jaren W, Ma, Wendy W, McCush, Fred, Alvey, Christine, Kupiec, James W, Bednar, Martin M
Published in Clinical neuropharmacology (01.01.2013)
Published in Clinical neuropharmacology (01.01.2013)
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