Stability surveillance testing: an effective and efficient approach.

J P de Kleijn; J Lakeman

doi:10.1002/jps.2600821113

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Stability surveillance testing: an effective and efficient approach.

J P de Kleijn·J Lakeman

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Abstract

Stability surveillance programs are run to confirm on a regular basis the registered shelf-life of pharmaceutical products in relation to the relevant climatic zone(s). The "selected date" and the "fixed interval" procedures are compared with respect to their applicability for obtaining a reliable estimate of the true shelf-life. Advantages of the selected date over the fixed interval approach are (1) a more reliable estimate of the true shelf-life, and (2) a more efficient approach in terms of time and costs.

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Chemistry, Pharmaceutical Climate Costs and Cost Analysis Decision Making Drug Stability Time Factors Journal Article

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J P de Kleijn, J Lakeman. 1993. Stability surveillance testing: an effective and efficient approach.. https://doi.org/10.1002/jps.2600821113

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