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Validierung bioanalytischer Methoden
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In diesem Buch wird die Validierung bioanalytischer Methoden beschrieben. Bei der Qualittskontrolle von biologischen Arzneimitteln kommen hufig bioanalytische Methoden zum Einsatz, um wichtige Eigenschaften wie den Gehalt oder mgliche Verunreinigungen zu berprfen. Die eingesetzten Methoden mssen vertrauenswrdige Ergebnisse liefern, damit bei der Bewertung der Ergebnisse keine falschen Schlsse gezogen werden. Die Vertrauenswrdigkeit wird durch eine Validierung sichergestellt. Die Validierung von bioanalytischen Methoden wird anhand einiger Beispiele dargestellt.
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