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Arzneimittelforschung Nach Der Zulassung: Bestandsaufnahme Und Perspektiven by N. Victor, H. Schäfer, H. Nowak

Arzneimittelforschung Nach Der Zulassung: Bestandsaufnahme Und Perspektiven

by N. Victor , H. Schäfer , H. Nowak
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Book cover type: Paperback
  • ISBN13: 9783540537984
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Springer
  • Publisher Imprint: Springer
  • Publication Date:
  • Pages: 92
  • Original Price: EUR 51.39
  • Language: German
  • Edition: N/A
  • Item Weight: 186 grams
  • BISAC Subject(s): Biostatistics

Die klinische Prüfung von Arzneimitteln vor der Zulassung hat einen hohen wissenschaftlichen Standard erreicht. Das vorliegende Buch macht deutlich, da diese Forschungsphase aufgrund der zeitlichen Limitierung dennoch keine abschlie enden Ergebnisse hinsichtlich Wirksamkeit und Sicherheit eines Arzneimittels liefern kann. Eine kontinuierliche begleitende Forschung auch nach der Zulassung eines Arzneimittels ist daher unabdingbar und liegt gleicherma en im Interesse von Patienten, Ärzten und Arzneimittelherstellern. In umfassender und systematischer Weise wird die Vielfalt der Fragestellungen einer Arzneimittelforschung nach der Zulassung herausgearbeitet und deutlich gemacht, da nur eine erhebliche Ausweitung des Methodenspektrums über die bekannten Methoden hinaus diesen Anforderungen gerecht werden kann. Das Buch bietet eine systematische Beschreibung der wichtigsten methodischen Instrumente, wobei besonders ausführlich die Studienform und Methoden der sog. Pharmakoepidemiologie behandelt werden, für die bisher keine Verfahrensrichtlinien und Qualitätsnormen existierten. Zahlreiche Wissenschaftler und Experten aus den Bereichen Biometrie, Pharmakologie und Innere Medizin haben zu diesem Buch beigetragen. Es ist die bisher einzige so umfassende und systematische Darstellung des Themas "Arzneimittelforschung nach der Zulassung" in der deutschsprachigen Fachliteratur. Die Realisierung des aufgezeigten Forschungsbedarfs nach der Zulassung eines Arzneimittels bei Arzneimittelherstellern, der Ärzteschaft, Behörden und Forschungseinrichtungen und der sachgerechte Einsatz des in diesem Buch beschriebenen Methodenrepertoires kann einen wesentlichen Beitrag zur Erhöhung der Arzneimittelsicherheit leisten.

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