:: Volume 2, Issue 1 And 2 (5-2015) ::
vacres 2015, 2(1 And 2): 29-32 Back to browse issues page
Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol
SM Hosseini, SB Momen, D Doroud, SN Hoseini, K Maboudi, Sh Hadadian *
Pasteur Institute of Iran
Abstract:   (3321 Views)

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.

Keywords: ICH, FDA, Hepatitis B vaccine, shelf-life, expiration date.
Full-Text [PDF 365 kb]   (2141 Downloads)    
Type of Study: Original article |
Received: 2015/12/21 | Accepted: 2015/12/21 | Published: 2015/12/21



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Volume 2, Issue 1 And 2 (5-2015) Back to browse issues page