Current Trends in Monoclonal Antibody Development and Manufacturing
Bestellnummer: 20778584
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Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
- 2009, XIV, 354 Seiten, 17 farbige Abbildungen, 5 Schwarz-Weiß-Abbildungen, Maße: 18,3 x 26 cm, Gebunden, Englisch
- Verlag: Springer Berlin
- ISBN-10: 0387766421
- ISBN-13: 9780387766423
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171.19 €
149.79 €
192.59 €
235.39 €
161.50 €
219.99 €
139.09 €
299.59 €
213.99 €
219.99 €
319.93 €
106.50 €
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- Kauf auf Rechnung
- Kostenlose Rücksendung
- Ratenzahlung möglich
Keine Kommentare vorhanden
Jetzt bewertenSchreiben Sie den ersten Kommentar zu "Current Trends in Monoclonal Antibody Development and Manufacturing".
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