Biosimilarity : The FDA Perspective /
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other reg...
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Main Author: | |
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Corporate Author: | |
Format: | Electronic eBook |
Language: | English |
Published: |
Boca Raton, FL :
CRC Press,
[2018]
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Edition: | First edition. |
Subjects: | |
Online Access: | Full text (WIT users only) |