Zusammenfassung
Untersuchungen zur relativen und/oder absoluten Bioverfügbarkeit eines Arzneistoffes sowie Untersuchungen zur Bioäquivalenz sind wichtige Verfahren im Rahmen des Nachweises von Qualität, Wirksamkeit und Unbedenklichkeit von Arzneimitteln. Auch im Rahmen der nationalen Zulassung von pflanzlichen Arzneimitteln können in Deutschland entsprechende Daten gefordert werden; solche Untersuchungen können auch Bestandteil der toxikologischen und pharmakologischen Dokumentation sein. Studien zur absoluten Bioverfügbarkeit werden dabei für Phytopharmaka eher die Ausnahme sein und höchstens im Rahmen der Arzneiform-oder Arzneistoffentwicklung eine Rolle spielen. Untersuchungen zur relativen Bioverfügbarkeit können dagegen nicht nur bei der Entwicklung, sondern auch bei bereits zugelassenen Präparaten sinnvoll sein. Vergleichende Untersuchungen zur pharmazeutischen Äquivalenz (Wirkstofffreisetzung/Dissolution-Test) dienen der Charakterisierung der Arzneiform.
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Gräfe, E.U., Veit, M. (1999). Untersuchungen zur systemischen Verfügbarkeit von pflanzlichen Wirkstoffen — unter welchen Voraussetzungen sind sie sinnvoll und wünschenswert?. In: Loew, D., Blume, H., Dingermann, T. (eds) Phytopharmaka V. Steinkopff, Heidelberg. https://doi.org/10.1007/978-3-642-58709-2_8
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DOI: https://doi.org/10.1007/978-3-642-58709-2_8
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