INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY
Merits and demerits of six ways of an assessment of an intermediate precision (IP) for validation of analytical methods are considered. It is established that only four of them can be recommended for IP assessment, and three - with restrictions Recommendations about use of the considered ways of an...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/229 |
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| _version_ | 1849395880064450560 |
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| author | N. A. Epshtein |
| author_facet | N. A. Epshtein |
| author_sort | N. A. Epshtein |
| collection | DOAJ |
| description | Merits and demerits of six ways of an assessment of an intermediate precision (IP) for validation of analytical methods are considered. It is established that only four of them can be recommended for IP assessment, and three - with restrictions Recommendations about use of the considered ways of an assessment of IP are made. It is shown that use of the most widely applied way of an assessment of intermediate precision - on a relative standard deviation of set of results of chemists, can lead to receiving a wrong conclusion about an IP of a method. It is offered the new (most universal) way of an assessment of an intermediate precision, that has perspective of application in pharmacy. |
| format | Article |
| id | doaj-art-333fc57d575b49e6ace063e809537896 |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-333fc57d575b49e6ace063e8095378962025-08-20T03:39:29ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0101106117229INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACYN. A. Epshtein0Autonomous Incorporation «STADAPharmdevelopment», JSC «NIZHPHARM»Merits and demerits of six ways of an assessment of an intermediate precision (IP) for validation of analytical methods are considered. It is established that only four of them can be recommended for IP assessment, and three - with restrictions Recommendations about use of the considered ways of an assessment of IP are made. It is shown that use of the most widely applied way of an assessment of intermediate precision - on a relative standard deviation of set of results of chemists, can lead to receiving a wrong conclusion about an IP of a method. It is offered the new (most universal) way of an assessment of an intermediate precision, that has perspective of application in pharmacy.https://www.pharmjournal.ru/jour/article/view/229validationintermediate precisionintra-laboratory precisionwithin-laboratory precisionwithin-laboratory reproducibilityruggedness |
| spellingShingle | N. A. Epshtein INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY Разработка и регистрация лекарственных средств validation intermediate precision intra-laboratory precision within-laboratory precision within-laboratory reproducibility ruggedness |
| title | INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY |
| title_full | INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY |
| title_fullStr | INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY |
| title_full_unstemmed | INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY |
| title_short | INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY |
| title_sort | intermediate precision determination at validation of methods in pharmacy |
| topic | validation intermediate precision intra-laboratory precision within-laboratory precision within-laboratory reproducibility ruggedness |
| url | https://www.pharmjournal.ru/jour/article/view/229 |
| work_keys_str_mv | AT naepshtein intermediateprecisiondeterminationatvalidationofmethodsinpharmacy |