Matrixing Designs for Shelf-Life Determination of Parenteral Drug Product: A Comparative Analysis of Full and Reduced Stability Testing Design.

ABSTRACT: This article highlights the applicability of matrixing designs in stability studies for parenteral medications. The traditional approach involves extensive testing over the product's shelf-life. However, matrixing designs offer an alternative approach where only a fraction of samples is tested at each time point. The study conducted in this article focused on three parenteral medications and examined stability data under long-term condition. Degradation products were identified as critical parameter, and kinetics of degradation varied among the selected products. A systematic methodology was adopted to evaluate the data using different matrixing designs. The regression models obtained were assessed using statistical parameters S and R². Also, each of the 28 matrixing designs wer

SUBMITTER: Pavcnik L 

PROVIDER: S-EPMC11435299 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature