STABILITY SURVEILLANCE TESTING - AN EFFECTIVE AND EFFICIENT APPROACH

Authors
DEKLEIJN JP LAKEMAN J
Citation
Jp. Dekleijn et J. Lakeman, STABILITY SURVEILLANCE TESTING - AN EFFECTIVE AND EFFICIENT APPROACH, Journal of pharmaceutical sciences, 82(11), 1993, pp. 1130-1133
Citations number
4
Categorie Soggetti
Chemistry,"Pharmacology & Pharmacy
Journal title
Journal of pharmaceutical sciences → ACNP
ISSN journal
00223549
Volume
82
Issue
11
Year of publication
1993
Pages
1130 - 1133
Database
ISI
SICI code
0022-3549(1993)82:11<1130:SST-AE>2.0.ZU;2-0
Abstract
Stability surveillance programs are run to confirm on a regular basis the registered shelf-life of pharmaceutical products in relation to th e relevant climatic zone(s). The ''selected date'' and the ''fixed int erval'' procedures are compared with respect to their applicability fo r obtaining a reliable estimate of the true shelf-life. Advantages of the selected date over the fixed interval approach are (1) a more reli able estimate of the true shelf-life, and (2) a more efficient approac h in terms of time and costs.