Considerations for drug development biomarker assays in the clinical laboratory-Reference-Cited by-同舟云学术

Considerations for drug development biomarker assays in the clinical laboratory

Published:2023-05 Issue:10 Volume:15 Page:533-536
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Arnold Mark E¹^ORCID,Allinson John L²^ORCID,Piccoli Steven P³^ORCID

Affiliation:

1. Bioanalytical Solution Integration, Westampton, NJ 08060, USA

2. Immunologix Laboratories, Biomarker Laboratory, Immunologix Laboratories, Tampa, FL 33634, USA

3. Clinical Sciences, Sun Pharma Advanced Research Company Ltd., Cranbury, NJ 08512, USA

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2023-0101

Reference6 articles.

1. US FDA. National Institute of Health (FDA-NIH), FDA-NIH Biomarker Working Group. Biomarkers, EndpointS, and other Tools Resource [Internet] Glossary (2023). http://www.ncbi.nlm.nih.gov/books/NBK338448/

2. US FDA. Bioanalytical Method Validation; guidance for industry (2018). www.fda.gov/downloads/drugs/guidances/UCM070107.pdf

3. Analytical method validation for biomarkers as a drug development tool: points to consider

4. Japan Ministry of Health, Labour and Welfare. Guideline on bioanalytical method validation in pharmaceutical development (2013). https://www.pmda.go.jp/files/000206209.pdf

5. Japan Ministry of Health, Labour and Welfare. Guideline on bioanalytical method (ligand binding assay) validation in pharmaceutical development (2014). https://www.pmda.go.jp/files/000206208.pdf

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