Funder
DH | National Institute for Health Research
Publisher
Springer Science and Business Media LLC
Subject
Biomedical Engineering,Molecular Medicine,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology
Cited by
13 articles.
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1. The importance of World Health Organization international reference standards in the product life cycle of biosimilars;Annals of the New York Academy of Sciences;2024-09-10
2. Quantification of SARS-CoV-2 monoclonal IgG mass fraction by isotope dilution mass spectrometry;Analytical and Bioanalytical Chemistry;2024-03-01
3. International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update;Biological Products. Prevention, Diagnosis, Treatment;2023-12-17
4. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine);Bioanalysis;2023-08
5. The landscape of biosimilars in Saudi Arabia: preparing for the next decade;Expert Opinion on Biological Therapy;2023-07-28