Basic requirements for biological criteria in drug quality evaluation. validation of biological control methods

Autor:	N. P. Neugodova, M. S. Ryabtseva, G. A. Sapozhnikova
Jazyk:	ruština
Rok vydání:	2018
Předmět:	контроль качества биологические показатели аномальная токсичность бактериальные эндотоксины условия тестирования валидация quality control biological criteria abnormal toxicity bacterial endotoxins test conditions validation Medicine (General) R5-920
Zdroj:	Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 3, Pp 3-8 (2018)
Druh dokumentu:	article
ISSN:	3034-3062 3034-3453
Popis:	Drug quality evaluation and control involve extensive use of biological methods in addition to chemical, physico-chemical and microbiological ones in order to ensure drug identity, purity and safety. Basic requirements for biological testing criteria are stated in the State Pharmacopoeia of the Russian Federation, however some aspects of testing are not described in sufficient detail and depend on the nature of a medicine to be tested. The present article describes basic requirements for introducing «Bacterial endotoxins» and «Abnormal toxicity» parameters to normative documentation. It also outlines basic aspects of test conditions validation and determination of an adequate level of drug quality standards.
Databáze:	Directory of Open Access Journals
Externí odkaz:	https://doaj.org/article/2f5f036de41847018dbdd5803413a1ff Zobrazit plný text záznamu View record in DOAJ