Author:
Ramanan Sundar,Grampp Gustavo
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,General Medicine,Biotechnology
Reference37 articles.
1. US Food and Drug Administration. What is a biological product? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194516.htm . Accessed 20 Sept 2013.
2. Genazzani AA, Biggio G, Caputi AP, Del Tacca M, Drago F, Fantozzi R, Canonico PL. Biosimilar drugs: concerns and opportunities. BioDrugs. 2007;21(6):351–6.
3. Wiggins JM, Skutnik J, Shimek-Cox J, Schwarzwalder N. The ideal pharmacopeia: a model for the future. Pharm Technol. 2008;32(11):122–5.
4. Crommelin DJ, Storm G, Verrijk R, de Leede L, Jiskoot W, Hennink WE. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs. Int J Pharm. 2003;266(1–2):3–16.
5. Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22(11):1383–91. doi: 10.1038/nbt1030 .
Cited by
72 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献