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Shashi Amur

Center for Drug Evaluation and Research

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FDA Experience with Regulation of Naloxone Products to Address the Opioid Crisis and Opportunities for Leveraging Scientific Engagement

2020 Clinical Pharmacology & Therapeutics
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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

2019 Bioanalysis
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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

2019 Bioanalysis
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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

2018 Bioanalysis
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Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification

2018 Clinical Pharmacology & Therapeutics
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Current status and future opportunities in lung precision medicine research with a focus on biomarkers: An American Thoracic Society/National Heart, Lung, and Blood Institute Research Statement

2018 American Journal of Respiratory and Critical Care Medicine
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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

2018 Bioanalysis
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2017 White Paper on recent issues in bioanalysis: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

2017 Bioanalysis
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Patient-Centered Therapy Development for Myotonic Dystrophy: Report of the Myotonic Dystrophy Foundation–Sponsored Workshop

2017 Therapeutic Innovation & Regulatory Science
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Employing “FDAlabel” Database to Extract Pharmacogenomics Information from FDA Drug Labeling to Advance the Study of Precision Medicine

2017
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