Figure - PMC

Skip to main content

An official website of the United States government

Here's how you know

Here's how you know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

View full-text article in PMC

. 2017 Dec 27;11:113–121. doi: 10.2147/OTT.S153056

Search in PMC
Search in PubMed
View in NLM Catalog
Add to search

© 2018 Fleisher and Ait-Oudhia. This work is published and licensed by Dove Medical Press Limited

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

PMC Copyright notice

Of the 15 biologic therapeutics for oncology published between 2005 and 2016 in FDA’s Purple Book, 5 drugs had defined positive E–R relationship for both efficacy and safety.

Note: Blincyto^® (blinatumomab [Amgen, Thousand Oaks, CA, USA]) had nearly 2-fold the fluctuation in serum concentration as compared to the drug, with the second highest fluctuation in serum concentration and documented safety E–R relationship suggesting significant fluctuations in serum concentrations and, therefore, increased risk of either suboptimal disease control in patients with high CL or increased risk of adverse drug reactions in patients with low CL.

Abbreviations: CL, clearance; E–R, exposure–response; FDA, US Food and Drug Administration; IIV, inter-individual variability; PK, pharmacokinetics; Vc, central volume of distribution.