AN ALTERNATIVE APPROACH TO THE ASSIGNMENT OF EXPIRATION DATES FOR DRUG PRODUCTS

Label claims equivalent to ''Store below 30 degrees C'' in all countri es of the globe are often the goal of pharmaceutical companies. It is also in the patients' interest that, wherever possible, the longest ex piration date which can be fully justified for the environment in whic h the product is used, is allocated. In some countries this requires a ssessment of data generated by continuous storage at 30 degrees C. In other countries the claim can be based on continuous storage at 25 deg rees C. For most products where such a label claim is likely, there is usually little, if any, difference between data generated at 25 degre es C and 30 degrees C at early timepoints. At later timepoints signifi cant differences may emerge which allow different shelf-lives to be al located. This paper describes a technique which allows both claims to be supported statistically without the need to perform parallel testin g at both 25 degrees C and 30 degrees C at early timepoints.