Biomarker assays: is it time for a standalone regulatory guidance?
Author:
Affiliation:
1. AbbVie Biotherapeutics 1500 Seaport Blvd Redwood City, CA 94063, USA
2. Biogen, 225 Binney Street, Cambridge, MA 02142, USA
Publisher
Future Science Ltd
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Link
http://www.future-science.com/doi/pdf/10.4155/bio-2018-0279
Reference13 articles.
1. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)
2. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)
3. Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement
4. Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics
5. Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective
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1. 2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation);Bioanalysis;2022-05
2. 2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2021-03
3. Identification of β-hydroxybutyrate as a potential biomarker for female papillary thyroid cancer;Bioanalysis;2019-03
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