Publications by authors named "Mitra Azadeh"

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Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR.
Jason Pennucci, Amanda Hays, Wendy Adamowicz, Mitra Azadeh, Mohamed Benhammadi

AAPS J· September 2025

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Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Mitra Azadeh

AAPS J· September 2024

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Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment.
Mitra Azadeh, Jeremy Good, Michele Gunsior, Nadia Kulagina, Yanmei Lu

AAPS J· August 2024

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Neutralizing Antibody Sample Testing and Report Harmonization.
Darshana Jani, Michele Gunsior, Robin Marsden, Kyra J Cowan, Susan C Irvin, Mitra Azadeh

AAPS J· July 2024

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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, Meenu Wadhwa, Katherine Block, Mitra Azadeh

Bioanalysis· June 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 - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Mike Baratta, Wenying Jian, Shawna Hengel, Surinder Kaur, Jennifer Cunliffe, Mitra Azadeh

Bioanalysis· June 2024

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Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Amanda Hays, Mark Wissel, Kelly Colletti, Russell Soon, Mitra Azadeh

AAPS J· February 2024

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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 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Mitra Azadeh

Bioanalysis· August 2023

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Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
Boris Gorovits, Mitra Azadeh, George Buchlis, Michele Fiscella, Travis Harrison

AAPS J· April 2023

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Synaptic proteins in neuron-derived extracellular vesicles as biomarkers for Alzheimer's disease: novel methodology and clinical proof of concept.
Erez Eitan, Tricia Thornton-Wells, Katya Elgart, Eren Erden, Eve Gershun, Mitra Azadeh

Extracell Vesicles Circ Nucl Acids· March 2023

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Anti-drug Antibody Sample Testing and Reporting Harmonization.
Darshana Jani, Robin Marsden, Michele Gunsior, Laura Schild Hay, Bethany Ward, Mitra Azadeh

AAPS J· October 2022

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Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.
Boris Gorovits, Mitra Azadeh, George Buchlis, Travis Harrison, Mike Havert

AAPS J· September 2021

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Mitra Azadeh

Bioanalysis· March 2021

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Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift.
Mitra Azadeh, Perceval Sondag, Ying Wang, Maribeth Raines, Jeffrey Sailstad

AAPS J· July 2019

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Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.
Mitra Azadeh, Boris Gorovits, John Kamerud, Stephen MacMannis, Afshin Safavi

AAPS J· December 2017

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A Rapid Two-Step Iduronate-2-Sulfatatse Enzymatic Activity Assay for MPSII Pharmacokinetic Assessment.
Mitra Azadeh, Luying Pan, Yongchang Qiu, Ruben Boado

JIMD Rep· June 2017

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