Latest features in GaBI Journal, 2021, Issue 3

Abstract

This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty associated with extrapolating results of studies that used small, non-representative study populations, study sites, or product types. These problems are evident in the evaluation of three articles in this issue. Other articles illustrate difficulties evaluating published opinions without access to the original data upon which such opinions were based: the need to evaluate the possible effects of real or potential conflicts of interest; and the lack of consistent regulatory approaches to important, non-pharmaceutical chemicals.