THE ROLE OF REFERENCE STANDARDS IN QUALITY ASSURANCE FOR MEDICINES: REGULATORY AND METROLOGICAL ASPECTS

Some aspects of the adequate use of reference standards (RS) for making a reliable decision on the compliance of medicines are reviewed. An analysis of the specificity of using RS with the certified value and substance/reagent, for which the nominal value is considered to be 100%, is conducted. Stat...

Бүрэн тодорхойлолт

Номзүйн дэлгэрэнгүй
Үндсэн зохиолчид: D. A. Leontiev, Y. V. Podpruzhnikov, N. V. Volovyk
Формат: Өгүүллэг
Хэл сонгох:Russian
Хэвлэсэн: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Цуврал:Разработка и регистрация лекарственных средств
Нөхцлүүд:
Онлайн хандалт:https://www.pharmjournal.ru/jour/article/view/308