Trend analysis of batch to batch consistency during quality assessment of biological medicinal products

The statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’...

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Hlavní autor: D. S. Davydov
Médium: Artigo
Jazyk:Russo
Vydáno: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Edice:Биопрепараты: Профилактика, диагностика, лечение
Témata:
управление качеством
биологические лекарственные препараты
вакцины
подтверждение соответствия
контрольные карты
quality management
biological medicinal products
vaccines
conformity assessment
control charts
On-line přístup:https://www.biopreparations.ru/jour/article/view/109
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