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

. 2018 Feb 1;7(3):135–146. doi: 10.1002/psp4.12282

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

© 2018 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

PMC Copyright notice

Quantitative systems pharmacology (QSP) model initiation by stage of drug discovery/development. (a) The QSP models are being implemented across all stages of drug discovery/development. (b) Three companies are implementing QSP modeling at the target validation stage only, whereas 20 initiate at clinical candidate selection (CCS) or later. Of those 20, 60% also have activities prior to CCS. Those who only initiated QSP at CCS or later were examined further to understand the role of PBPK and FIH support. (c) In these cases, all considered mechanistic physiologically based pharmacokinetic (PBPK) as a type of QSP model, suggesting that QSP may be used in clinical dose prediction or related pharmacokinetic questions. This hypothesis may be strengthened by the fact that seven of the eight responders also sited that QSP modeling was used to support first‐in‐human (FIH) studies.