Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry-Reference-Cited by-同舟云学术

Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry

Published:2021-05 Issue:10 Volume:13 Page:737-740
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Amaravadi Lakshmi¹,Palackal Nisha²,Garofolo Fabio³

Affiliation:

1. Boston Pharmaceuticals, Cambridge, MA, USA

2. Regeneron Pharmaceuticals, Tarrytown, NY, USA

3. BRI, Vancouver, BC, Canada

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-2021-0086

Reference21 articles.

1. US FDA. Bioanalytical Method Validation Guidance for Industry (2018). https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf

2. European Medicines Agency, Committee for Medicinal Products for Human use. Guideline on Bioanalytical Method Validation (2011). https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation en.pdf

3. ICH. ICH M10, Draft Bioanalytical Method Validation (2019). http://www.ich.org/fileadmin/Public Web Site/ICH Products/Guidelines/Multidisciplinary/M10/M10EWG Step2 DraftGuideline 2019 0226.pdf

4. The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

5. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

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