Computer-implemented methods for evaluating, summarizing and presenting data on stability of drug substances and drug products and software-modified computers for such methods

摘要

Computer-implemented methods for statistical analysis and summarization of a stability study on a pharmaceutical product using of a macro integrated into statistical analysis software. The method includes inputting and summarizing data observed for a stability study on a pharmaceutical product, statistically analyzing the data, including using at least one regression function to characterize the time-response relationship of at least one stability response variable, to estimate a shelf life of the pharmaceutical product or confirm the shelf life of an existing pharmaceutical product, and providing standardized output data and graphical presentations of observed stability response data. Also, a computer loaded with a general statistical analysis software and a macro integrated with the software such that the computer is capable of performing these computer-implemented methods using the software and macro.