AU - Hosseini, SM AU - Momen, SB AU - Doroud, d AU - Hoseini, SN AU - Maboudi, K AU - Hadadian, Sh TI - Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol PT - JOURNAL ARTICLE TA - vacres JN - vacres VO - 2 VI - 1 IP - 1 4099 - http://vacres.pasteur.ac.ir/article-1-60-en.html 4100 - http://vacres.pasteur.ac.ir/article-1-60-en.pdf SO - vacres 1 ABĀ  - 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. CP - IRAN IN - LG - eng PB - vacres PG - 29 PT - Original article YR - 2015