Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol

Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol

Blog Article

Introduction: Pharmaceutical companies as well as food and cosmetics manufacturers are legally required to provide a shelf-life bostik roll-cote 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 animed aniflex complete 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.