Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Authors: Garcia-Arieta A

One of the significant challenges faced by pharmaceutical companies is the sometimes unclear guidance on what data regulators want to see included in their submissions and the format in which it should be provided.

QSP in the Real World: Where Has Quantitative Systems Pharmacology (QSP) Been Used to Support Drug Development and With What Impact?

QSP in the Real World: Where Has Quantitative Systems Pharmacology (QSP) Been Used to Support Drug Development and With What Impact?

Authors: Shoda L

Quantitative systems pharmacology (QSP) is gaining acceptance and utilization in many drug development programs, but even those who appreciate its value may not fully recognize the extent to which it has already achieved impact and/or its range of potential applications.