Clinical Pharmacology – Chemical
2019 PharmSci 360
Identifying the dose is possibly the most critical task during drug development. Traditional PKPD approaches , founded on the basis of receptor pharmacology principles, have been successful in identifying doses in a majority of cases. But in many cases, the complexity of the mechanism requires more complex modelling approaches such as quantitative systems pharmacology (QSP) to identify doses, especially during early clinical development.
Examples will be provided where a QSP approach was successful in providing guidance on dose during drug development, when a more traditional PKPD approach provided limited utility. Investing in QSP could have other parallel benefits as well like identification of predictive biomarkers.