Design and Analysis of Follow-On Biologics
|Series title:||Chapman and Hall/CRC Biostatistics Ser.|
|Publication Date:||Jul 2013|
| Publisher:||CRC Press LLC|
| Imprint:||Chapman & Hall/CRC|
| Book Format:||Hardback|
|List Price:||USD $94.95|
| Book Description: |
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 challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products.
Written by a top biostatistics researcher, Biosimilars: Design and...