Part 2: Physicochemical characterization of bevacizumab in 2 mg/mL antibody solutions as used in human i.v. administration: Comparison of originator with a biosimilar candidate

Author:

Arvinte Tudor,Palais Caroline,Poirier Emilie,Cudd Amelia,Rajendran Shanthi,Brokx Stephen,Dowd Jason

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference30 articles.

1. Physicochemical characterization of bevacizumab in undiluted 25 mg/mL drug product solutions: comparison of originator with a biosimilar candidate;Arvinte;J. Pharm. Biomed. Anal.,2019

2. AVASTIN® (bevacizumab) Full Prescribing Information,2015

3. Avastin®. Summary of Product Characteristics. European Medicines Agency (EMA), https://www.ema.europa.eu/documents/product-information/avastin-epar-product-information_en.pdf. (Accessed 13 June 2019).

4. Aggregation of biopharmaceuticals in human plasma and human serum. Implication for drug research and development;Arvinte;mAbs,2013

5. ICH Harmonised Tripartite Guideline, Pharmaceutical Development. Q8(R2) Step 4 version, August 2009. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. (Accessed 07 June 2019).

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