shelf-life estimation of recombinant hepatitis b vaccine using r software in comparison with who manual protocol

introduction: pharmaceutical companies as well as food and cosmetics manufacturers are legally required to provide a shelf-life label on their products packaging as part of their stability study report. there are different recommended software like r software package and sas which can perform as shelf-life estimating tools for analyzing the data achieved by the stability testing of drugs and vaccines. methods: recombinant hepatitis b surface antigen vaccine (pasteur institute of iran) was used as a sample for the entire quality control assays according to pharmacopeia and nih (national institute of health) procedures. for the stability study, full test examinations were done and r software package was applied to estimate the shelf-life. results: the results of r software indicated a variety of statistical information which makes the data interpretation more intelligible and apprehensible. conclusion: based on our results and experience, the best way to obtain a shelf-life or the expiration date is to calculate it manually however, using software such as r can increase the accuracy of the results.