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Sci. Pharm.
Volume 70
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10.3797/scipharm.aut-02-02
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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Article

Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline

by
Edlinger I.
1,
Liebenberger I.
1,
Macas R.
1,
Mayrhofer A.
1,*,
Stouer S.
1,* and
Wirthumer-Hoche C.
2
1
Bundesinstitut für Arzneimittel (BIfA), Zimmermanngasse 3, A-I095 Wien
2
Bundesministerium für soziale Sicherheit und Generationen, Radetzkystr. 2, A-I 030 Wien
*
Authors to whom correspondence should be addressed.
Sci. Pharm. 2002, 70(1), 15-24; https://0-doi-org.brum.beds.ac.uk/10.3797/scipharm.aut-02-02
Submission received: 21 September 2001 / Revised: 5 November 2001 / Accepted: 5 November 2001 / Published: 10 January 2002
Versions Notes

Abstract

The in-use stability of 25 drug products (oralliquids) with sensitive active ingredients was tested with a new test design simulating the stress of practical use. The results showed in so me cases a dramatic degradation of the active ingredient and the need of a reduced shelf life after first opening. Therefore the topic "in-use stability testing of human medicinal products" was brought forward to the QWP of the CPMPc by a member of the BlfA. Austria was appointed as rapporteur for the elaboration of the corresponding guideline.
Keywords: instability of drug products after first opening, new CPMP guideline for in-use stability testing of human medicinal products instability of drug products after first opening, new CPMP guideline for in-use stability testing of human medicinal products

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MDPI and ACS Style

I., E.; I., L.; R., M.; A., M.; S., S.; C., W.-H. Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline. Sci. Pharm. 2002, 70, 15-24. https://0-doi-org.brum.beds.ac.uk/10.3797/scipharm.aut-02-02

AMA Style

I. E, I. L, R. M, A. M, S. S, C. W-H. Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline. Scientia Pharmaceutica. 2002; 70(1):15-24. https://0-doi-org.brum.beds.ac.uk/10.3797/scipharm.aut-02-02

Chicago/Turabian Style

I., Edlinger, Liebenberger I., Macas R., Mayrhofer A., Stouer S., and Wirthumer-Hoche C. 2002. "Haltbarkeit von Arzneimitteln nach Anbruch: Von der Marktüberwachungsstudie zur EU-Guideline" Scientia Pharmaceutica 70, no. 1: 15-24. https://0-doi-org.brum.beds.ac.uk/10.3797/scipharm.aut-02-02

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