Wentworth
Institute of Technology
Biosimilars : Design and Analysis of Follow-on Biologics.
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 ch...
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| Main Author: | |
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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken :
CRC Press,
2013.
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| Series: | Chapman & Hall/CRC biostatistics series.
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| Subjects: | |
| Online Access: |
Full text (WIT users only) |
| Summary: | 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 Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity. |
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| Physical Description: | 1 online resource (433 pages). |
| ISBN: | 9781466579705 1466579706 |
| Source of Description, Etc. Note: | Print version record. |