Mitra Azadeh

Synaptic proteins in neuron-derived extracellular vesicles as biomarkers for Alzheimer’s disease: novel methodology and clinical proof of concept

Erez Eitan, Tricia A. Thornton‐Wells, Katya Elgart et al. · Extracellular Vesicles and Circulating Nucleic Acids · 2023 · 66 citations · Full text

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 et al. · The AAPS Journal · 2017 · 48 citations · Full text

Engineering, Ligand Binding, Multivariate Calibration +22

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 et al. · The AAPS Journal · 2024 · 35 citations · Full text

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 et al. · The AAPS Journal · 2019 · 29 citations · Full text

Quality Controls, Ligand Binding Assays, Qc Life Cycle +18

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( <u>Part 2A</u> –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation &amp; Innovation <u>Part 2B</u> –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)

Susan Spitz, Yan Zhang, Sally Fischer et al. · Bioanalysis · 2021 · 24 citations