Stability surveillance testing: an effective and efficient approach.
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.
de Kleijn
J P
JP
Organon International BV, Oss, The Netherlands.
Lakeman
J
J
D002626:Chemistry, Pharmaceutical; D002980:Climate; D003365:Costs and Cost Analysis; D003657:Decision Making; D004355:Drug Stability; D013997:Time Factors