Despite much investment and progress, oncology is still an area with significant unmet
medical needs, with new therapies and more effective use of current therapies needed. The …

In oncology trials, overall survival (OS) is considered the most reliable and preferred
endpoint to evaluate the benefit of drug treatment. Other relevant variables are also …

Purpose Physiologically based pharmacokinetic (PBPK) modeling, a mathematical
modeling approach which uses a pharmacokinetic model to mimick human physiology to …

High drug attrition rates remain a critical issue in oncology drug development. A series of
steps during drug development must be addressed to better understand the …

Due to frequent clinical trial failures and consequently fewer new drug approvals, the need
for improvement in drug development has, to a certain extent, been met using model-based …

Abstract Purpose of Review Although significant progress has been made in cancer
research, there exist unmet needs in patient care as reflected by the “Cancer Moonshot” …

There is broad recognition, within the pharmaceutical industry that the drug development
process, especially the clinical part of it, needs considerable improvement to cope with rapid …

Introduction: Drug attrition in oncology clinical development is higher than in other
therapeutic areas. In this context, pharmacometric modeling represents a useful tool to …

Physiologically based pharmacokinetic (PBPK) modeling can be used to predict drug
pharmacokinetics in virtual populations using models that integrate understanding of …

Introduction: Modeling and simulation have become important means of answering
questions relevant to the development of a drug, making it possible to assess risks early and …