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

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HOSSEINI S.M.; Momen S.B.; Doroud D.; Hoseini S.N.; Maboudi K.; Hadadian Sh.

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Journal Paper

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Journal: VACCINE RESEARCH Year:2015 | Volume:2 | Issue:1-2 Page(s): 29-32

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Title

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

Author(s)

Keywords

ICH

FDA

Hepatitis B vaccine

shelf-life

expiration date

Abstract

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.

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APA: Copy

HOSSEINI, S.M., Momen, S.B., Doroud, D., Hoseini, S.N., Maboudi, K., & Hadadian, Sh.. (2015). Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol. VACCINE RESEARCH, 2(1-2), 29-32. SID. https://sid.ir/paper/344410/en

Vancouver: Copy

HOSSEINI S.M., Momen S.B., Doroud D., Hoseini S.N., Maboudi K., Hadadian Sh.. Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol. VACCINE RESEARCH[Internet]. 2015;2(1-2):29-32. Available from: https://sid.ir/paper/344410/en

IEEE: Copy

S.M. HOSSEINI, S.B. Momen, D. Doroud, S.N. Hoseini, K. Maboudi, and Sh. Hadadian, “Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol,” VACCINE RESEARCH, vol. 2, no. 1-2, pp. 29–32, 2015, [Online]. Available: https://sid.ir/paper/344410/en

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