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:: دوره 2، شماره 1 و 2 - ( 2-1394 ) ::
جلد 2 شماره 1 و 2 صفحات 29-32 برگشت به فهرست نسخه ها
Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol
چکیده:   (2754 مشاهده)

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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نوع مطالعه: Original article |
دریافت: ۱۳۹۴/۹/۳۰ | پذیرش: ۱۳۹۴/۹/۳۰ | انتشار: ۱۳۹۴/۹/۳۰
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Hosseini S, Momen S, Doroud D, Hoseini S, Maboudi K, Hadadian S. Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol. vacres. 2015; 2 (1 and 2) :29-32
URL: http://vacres.pasteur.ac.ir/article-1-60-fa.html

Shelf-life estimation of recombinant hepatitis B vaccine using R software in comparison with WHO manual protocol. تحقیقات واکسن. 1394; 2 (1 و 2) :29-32

URL: http://vacres.pasteur.ac.ir/article-1-60-fa.html



دوره 2، شماره 1 و 2 - ( 2-1394 ) برگشت به فهرست نسخه ها
تحقیقات واکسن Vaccine Research
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