The requirements for in vivo bioequivalence studies for solid products of oral drugs with narrow therapeutic indexes by FDA, HC, EMA, PMDA and CFDA
XU Wen-pin
LI Li
CHEN Li-xun
HE Rui-rui
HAN Hong-can
YANG Jin-bo
Abstract：Scientific consideration on study design and more strict bioequivalence (BE) acceptance limits are essential for in vivo BE studies of generic narrow therapeutic index (NTI) drugs,which is decided by the characteristics of NTI drugs.Currently,there are differences in the BE study requirements of NIT drugs among the main drug administration agencies,and there is no globally harmonized NTI list.Moreover,some drugs with steep dose-response relationship and high risk in use are not defined as NTI drugs.In this review,we summed up the requirements for in vivo BE studies of NTI drugs by FDA,HC,EMA,PMDA and CFDA,and collected the official NTI lists from those countries and regions,which will be helpful to optimize the BE studies of NTI drugs in China.
Keywords：narrow therapeutic indexbioequivalence studydrug administration
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2913-2917 )