Concepedia

Marcela Araya

MA

Statistics

Publications

3

Citations

267

H-Index

3

Active since

2008

Affiliations

United States Food and Drug Administration(Current)

Sanofi (United States)

Novartis (United States)

Bristol-Myers Squibb (United States)

Takeda (United States)

Marcela Araya is an author at United States Food and Drug Administration specializing in bioanalytical method validation, bioanalytical methodology, and human nutrition.

Publications per year

2008–2025

3

Publications

3

Physiological effects of broccoli consumption

Elizabeth H. Jeffery, Marcela Araya · Phytochemistry Reviews · 2008 · 231 citations

, , +5

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 · 26 citations · Full text

, , +16

2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( <u>Part 1A</u> – Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV)

John Wojcik, Timothy W. Sikorski, Jian Wang et al. · Bioanalysis · 2025 · 10 citations · Full text

, , +17

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