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de Kleijn JP, Lakeman J. Stability surveillance testing: an effective and efficient approach. J Pharm Sci. 1993;82(11):1130-3doi: 10.1002/jps.2600821113.
de Kleijn, J. P., & Lakeman, J. (1993). Stability surveillance testing: an effective and efficient approach. Journal of pharmaceutical sciences, 82(11), 1130-3. https://doi.org/10.1002/jps.2600821113
de Kleijn, J P, and Lakeman, J. "Stability surveillance testing: an effective and efficient approach." Journal of pharmaceutical sciences vol. 82,11 (1993): 1130-3. doi: https://doi.org/10.1002/jps.2600821113
de Kleijn JP, Lakeman J. Stability surveillance testing: an effective and efficient approach. J Pharm Sci. 1993 Nov;82(11):1130-3. doi: 10.1002/jps.2600821113. PMID: 8289127.
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Elsevier Science

J Pharm Sci. 1993 Nov;82(11):1130-3. doi: 10.1002/jps.2600821113.

Stability surveillance testing: an effective and efficient approach.

Journal of pharmaceutical sciences

J P de Kleijn, J Lakeman

Affiliations

  1. Organon International BV, Oss, The Netherlands.

PMID: 8289127 DOI: 10.1002/jps.2600821113

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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