Analytical Similarity Assessment in Biosimilar Product Development /
This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critica...
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| Main Author: | |
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| Corporate Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boca Raton, FL :
Chapman and Hall/CRC,
2018.
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| Edition: | First edition. |
| Subjects: | |
| Online Access: | Click here to view. |
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Analytical Similarity Assessment in Biosimilar Product Development /