Biosimilar and Interchangeable Biologics: Strategic Elements
โ Scribed by Sarfaraz K. Niazi
- Publisher
- CRC Press
- Year
- 2015
- Tongue
- English
- Leaves
- 646
- Category
- Library
No coin nor oath required. For personal study only.
๐ SIMILAR VOLUMES
"This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies u
<p>As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator`s biologic products. But scientific chal