Increasing knowledge of intertumor heterogeneity, intratumor heterogeneity, and cancer
evolution has improved the understanding of anticancer treatment resistance. A better …

Population modeling of tumor size dynamics has recently emerged as an important tool in
pharmacometric research. A series of new mixed‐effects models have been reported …

Historically, the evidences of safety and efficacy that companies provide to regulatory
agencies as support to the request for marketing authorization of a new medical product …

This document was developed to enable greater consistency in the practice, application,
and documentation of Model‐Informed Drug Discovery and Development (MID3) across the …

A milestone step in translational science to transform basic scientific discoveries into
therapeutic applications is the advancement of a drug candidate from preclinical studies to …

Recent data from immuno‐oncology clinical studies have shown the exposure–response (E–
R) relationship for therapeutic monoclonal antibodies (mAbs) was often confounded by …

There is a need for new approaches and endpoints in oncology drug development,
particularly with the advent of immunotherapies and the multiple drug combinations under …

Purpose Drug resistance is a major impediment to the success of cancer treatment.
Resistance is typically thought to arise from random genetic mutations, after which mutated …

Despite advances in biomedical research that have deepened our understanding of cancer
hallmarks, resulting in the discovery and development of targeted therapies, the success …

Inadequate dose selection for confirmatory trials is currently still one of the most challenging
issues in drug development, as illustrated by high rates of late‐stage attritions in clinical …