Analytical biosimilarity assessment relies on two implicit conditions. First, the analytical
method must meet a set of requirements known as fit for intended use related to trueness …

A novel approach for comparing quality attributes of different products when there is
considerable product-related variability is proposed. In such a case, the whole range of …

Abstract In 2017, Food and Drug Administration (FDA) circulated a draft guidance on
analytical similarity assessment to assist the sponsors for providing totality-of-the-evidence …

Abstract Recently in 2019, the United States Food and Drug Administration (FDA) circulated
a new draft guidance for comparative analytical assessment. They suggest the use of quality …

To assist the sponsor in biosimilar product development, the Food and Drug Administration
(FDA) recommends a stepwise approach for obtaining the totality-of-the-evidence for …

Biosimilar assessment has received much attention since the Biologics Price Competition
and Innovation (BPCI) Act passed by the United States (US) Congress in 2009. For …

For biosimilarity assessment between a proposed biosimilar (test) product and an innovative
biological (reference) product, the United States Food and Drug Administration (FDA) …

Biologic drug products are therapeutic moieties that are manufactured using a living system
or an organism, which are important life-saving drug products for patients with unmet …

„A 4.2. 1 részben populáció alatt a szerző a kezelésre szoruló betegeket jelenti,
perempopuláció alatt pedig azokat a betegeket, akiknél a túl magas koncentráció …