Original articleGuidelines for the practical stability studies of anticancer drugs: A European consensus conferenceRecommandations pour les essais de stabilité pratique des médicaments anticancéreux : une conférence de consensus européenne☆
Section snippets
Background
Stability studies performed by the pharmaceutical industry are only designed to fulfill licensing requirements. When medicines are being licensed, little attention is given to the practical use of these drugs and there is no recognition that pharmaceuticals start a new life once they are prepared for patient administration. When reviewing package inserts, the general assumption is that a drug will be reconstituted, if necessary, and administered on a clinical ward. But increasingly the
Methods
A European conference consensus was held in France, Abbaye des Vaux de Cernay, May 2010, under the auspices of the French Society of Oncology Pharmacy (SFPO) to define adapted rules on stability in practical situations and to propose guidelines to perform the corresponding stability studies. A panel of ten European experts shared their specific and “practical” experience and worked during two days to produce guidelines. This panel is referred as “consensus group”. Conference consensus was
Unresolved questions
After examination of the literature, the initial postulate was that many unresolved questions remained, such as:
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The relevant stability limits for practical purposes, including the question of those for degradation products.
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The kind of methods to be used when ICH guidelines are non adapted both for physical and chemical evaluation.
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The evolutions of protocols of stressed conditions.
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The need of more relevant design for stability studies (i.e. sequential cycling and non isothermal studies).
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The
Conclusion
All of the drugs used in modern medicine are licensed with very limited stability data which are insufficient to fulfil the new ways of drugs being handled in the 21st century clinical environment. As a consequence, there is an urgent need for additional data to support the pharmaceutical quality of these practices. Ideally, the drug development programs of pharmaceutical industry should generate enough stability data to allow for a more flexible clinical application, or would make available to
Disclosure of interest
The authors declare that they have no conflicts of interest concerning this article.
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Cited by (0)
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This article presents the outcomes from the SFPO First European workshop on methodology in drug stability studies in the field of oncology, 14–15 May, 2010, Abbaye-des-Vaux-de-Cernay, France.