Pooling of Batches for Stability Data Analysis: Stability studies are carried out to study the impact on the quality of drug substance or drug product over a period of time under the combined influence of environmental factors like temperature, humidity, and exposure to light. One of the main purpose of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. The spreadsheet is designed to meet the poolability criteria as per International Council for Harmonisation Harmonised Tripartite guideline for evaluation of stability data, Q1E

Stability studies in the pharmaceutical industry are intended to measure the degradation of drug product over time. These studies are conducted by taking random samples from a batch that is [...]