Analytical Similarity Assessment in Biosimilar Product Development
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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 will cover current issues, and recent development in analytical similarity assessment--
| Autor: | Chow, Shein-Chung; Shao, Jun; Wang, Hansheng |
| Nakladatel: | Taylor & Francis Ltd |
| ISBN: | 9781138307339 |
| Rok vydání: | 2018 |
| Jazyk : | Angličtina |
| Vazba: | Hardback |
| Počet stran: | 340 |
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