Immunogenicity and biomarkers: bioanalytical challenges and considerations-Reference-Cited by-同舟云学术

Immunogenicity and biomarkers: bioanalytical challenges and considerations

Published:2017-11 Issue:22 Volume:9 Page:1729-1732
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Gunn George R¹,Evans Christopher¹,Yang Eric¹

Affiliation:

1. Bioanalysis, Immunogenicity & Biomarkers, GlaxoSmithKline Pharmaceutical R&D 709 Swedeland Rd, King of Prussia, PA 19406, 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-2017-0184

Reference13 articles.

1. Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products (2014). www.fda.gov/downloads/drugs/guidances/ucm338856.pdf

2. Guideline on Immunogenicity assessment of therapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1) (2017). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf

3. Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

4. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival

5. Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development

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