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Validierung Bioanalytischer Methoden
Paperback
Series: Essentials
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ISBN13: 9783658319519
Publisher: Springer Spektrum
Published: Oct 19 2020
Pages: 55
Weight: 0.20
Height: 0.14 Width: 5.83 Depth: 8.27
Language: German
In diesem Buch wird die Validierung bioanalytischer Methoden beschrieben. Bei der Qualitätskontrolle von biologischen Arzneimitteln kommen häufig bioanalytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mögliche Verunreinigungen zu überprüfen. Die eingesetzten Methoden müssen vertrauenswürdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlüsse gezogen werden. Die Vertrauenswürdigkeit wird durch eine Validierung sichergestellt. Die Validierung von bioanalytischen Methoden wird anhand einiger Beispiele dargestellt.
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