Estimation of uncertainty of test methods and reference standards used for immunobiological medicines
The article summarises the results of analysis of guidelines and regulations as well as experience in validation of analytical methods and certification of reference standards (RS) of biological medicinal products. Based on the results of the analysis the authors propose an approach to estimation of...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
|
| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/78 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849342811358363648 |
|---|---|
| author | R. A. Volkova O. V. Fadeikina |
| author_facet | R. A. Volkova O. V. Fadeikina |
| author_sort | R. A. Volkova |
| collection | DOAJ |
| description | The article summarises the results of analysis of guidelines and regulations as well as experience in validation of analytical methods and certification of reference standards (RS) of biological medicinal products. Based on the results of the analysis the authors propose an approach to estimation of test methods and reference standards uncertainty to determine biologicals quality parameters in the context of intermediate precision/reproducibility. Expanded uncertainty of the test method was estimated as 2 standard deviations of the test results in the context of intermediate precision/reproducibility for the predetermined range of the tested parameters, and the uncertainty of the reference standards - as 2 standard deviations of the test results for the reference standards in the context of intermediate precision/reproducibility. Since reference standards for most biologicals are currently tested by the same method by which they were certified, an analytical system (a reference standard and a test method) is used as a means of measurement units representation. |
| format | Article |
| id | doaj-art-050c69ff6aca40f29302f98fce49dfb7 |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-050c69ff6aca40f29302f98fce49dfb72025-08-20T03:43:15ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-02-01171273178Estimation of uncertainty of test methods and reference standards used for immunobiological medicinesR. A. Volkova0O. V. Fadeikina1Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article summarises the results of analysis of guidelines and regulations as well as experience in validation of analytical methods and certification of reference standards (RS) of biological medicinal products. Based on the results of the analysis the authors propose an approach to estimation of test methods and reference standards uncertainty to determine biologicals quality parameters in the context of intermediate precision/reproducibility. Expanded uncertainty of the test method was estimated as 2 standard deviations of the test results in the context of intermediate precision/reproducibility for the predetermined range of the tested parameters, and the uncertainty of the reference standards - as 2 standard deviations of the test results for the reference standards in the context of intermediate precision/reproducibility. Since reference standards for most biologicals are currently tested by the same method by which they were certified, an analytical system (a reference standard and a test method) is used as a means of measurement units representation.https://www.biopreparations.ru/jour/article/view/78неопределенностьметодикастандартный образецбиологические лекарственные средстваuncertaintytest methodreference standardbiological medicinal products |
| spellingShingle | R. A. Volkova O. V. Fadeikina Estimation of uncertainty of test methods and reference standards used for immunobiological medicines Биопрепараты: Профилактика, диагностика, лечение неопределенность методика стандартный образец биологические лекарственные средства uncertainty test method reference standard biological medicinal products |
| title | Estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| title_full | Estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| title_fullStr | Estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| title_full_unstemmed | Estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| title_short | Estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| title_sort | estimation of uncertainty of test methods and reference standards used for immunobiological medicines |
| topic | неопределенность методика стандартный образец биологические лекарственные средства uncertainty test method reference standard biological medicinal products |
| url | https://www.biopreparations.ru/jour/article/view/78 |
| work_keys_str_mv | AT ravolkova estimationofuncertaintyoftestmethodsandreferencestandardsusedforimmunobiologicalmedicines AT ovfadeikina estimationofuncertaintyoftestmethodsandreferencestandardsusedforimmunobiologicalmedicines |