4-Week toxicity study of biosimilar natalizumab in comparison to Tysabri® by repeated intravenous infusion to cynomolgus monkeys
Author:
Affiliation:
1. Polpharma Biologics SA, Gdańsk, Poland;
2. LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Hamburg, Germany;
3. Gad Consulting Services, Raleigh, NC, USA
Publisher
Informa UK Limited
Subject
Chemical Health and Safety,Health, Toxicology and Mutagenesis,Public Health, Environmental and Occupational Health,Pharmacology,Toxicology,General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/01480545.2020.1722155
Reference33 articles.
1. Pharmacokinetic and toxicology comparator testing of biosimilar drugs – Assessing need
2. A 4-Week Intrathecal Toxicity and Pharmacokinetic Study With Trastuzumab in Cynomolgus Monkeys
3. Nonclinical safety testing of biopharmaceuticals – Addressing current challenges of these novel and emerging therapies
4. Preclinical Safety Evaluation of Biopharmaceuticals
5. Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
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