Introduction to the guidance for industry on liposome drug products:chemistry, manufacturing, and controls;human pharmacokinetics and bioavailability;and labeling documentation issued by FDA
ZHOU Yu
GONG Xin-jiang
YANG Jin-bo
Abstract：The US Food and Drug Administration ( FDA) issued the guidance for industry on liposome drug products: chemistry, manufacturing, and controls; human pharmacokinetics and bioavailability; and labeling documentation in April 2018. This guidance discusses what types of information should be submitted to CDER for new drug application ( NDA) or abbreviated new drug application ( ANDA) for a liposome drug product. The discussion addresses the following topics for liposome drug products: chemistry, manufacturing, and controls ( CMC) ; human pharmacokinetics and bioavailability or, in the case of an ANDA, bioequivalence; and labeling in NDAs and ANDAs. As there is no similar guidance in China currently, this article introduces the US guidance to provide some reference for the research, development and review of liposome drugs in China.
Keywords：FDAliposome drugsnew drug applicationabbreviated new drug applicationguidance
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1835-1840 )