Privatsphäre-Einstellungen

Auswertung und Optimierung von Haltbarkeitsuntersuchungen bei pharmazeutischen Produkten

2. Mitteilung: Anwendung*)

Martin Holz a, Donald Dill b, Christoph Kesselheim c und Theo Wember d

Datenanalyse Dr. Holz a, Neuenburg, A & M Stabtest b, Mainz, Byk Gulden c, Singen, und Statistikberatung d, Waltrop

Evaluation and Optimization of Shelflife Estimation in Pharmaceutical Products / 2nd Communication: Implementation

Application of modern statistical design-of-experiment (DoE) and regression tools for planning and analysis of drug stability studies helps to assure a sensitive assessment of relevant effects. Considerable saving of resources is possible without deteriorating the power of the study. In part one of this communication the theoretical background of DoE was introduced. The current work presents a practical example of its use with state-of-the-art software focussing on the relationship between saving potential and power.

Key words Haltbarkeitsuntersuchung · Regressionsanalyse · Studiendesign, lineares Modell, Matrixing, D-optimales Design

*)1. Mitteilung mit dem Titel „Grundlagen“ siehe Pharm. Ind.
63, Nr. 1 , S . 85 (2001).