ABSTRACT
In 1992, Australia adopted the guidelines of the European Union (EU) for the registration of new prescription pharmaceuticals and injectables. One might ask an Australian company what it wishes to write on the label in order to sell the product, and particularly if it also plans to market the product in the South East Asian region. The EU guideline for the stability testing of new drug products refers to the mathematical analysis of quantitative data, such as assay results, to produce a straight line regression and a 95 percent, one-sided confidence boundary. The stability study defines the loss of drug on storage, but the starting point for that loss is the lower release limit. The International Conference on Harmonisation parent stability guideline, adopted as the EU guideline, incorporates the concept of mean kinetic temperature, which was defined by Haynes in 1971.
