Stability shelf life estimation using linear regression models
Stability shelf life estimation using linear regression models
Authors
Elena Koleva
University of Chemical Technology and Metallurgy, 8 Kl. Ohridski, 1756 Sofia, Bulgaria
Toni Paneva
University of Chemical Technology and Metallurgy, 8 Kl. Ohridski, 1756 Sofia, Bulgaria
Vencislav Tzotchev
University of Chemical Technology and Metallurgy, 8 Kl. Ohridski, 1756 Sofia, Bulgaria
Abstract
The purpose of a drug product stability study is to elucidate the behavior of its quality attributes over time under the influence of different environmental conditions such as temperature, humidity, light, etc. and to define the retest period, the shelf-life as well as the suitable storage conditions for the drug. This paper presents data referring to the product degradation of three batches of a drug in the course of one year storage. The shelf life estimation is carried out using linear regression models. Poolability of the different batches data required for the application of the overall regression model is discussed.