Developing a medicine

This branch covers the scientific process of turning a candidate into a medicine, divided by the development questions a writer encounters: the sequence of stages, the models and safety studies that support human testing, biomarkers, and the economics of the pipeline. Drug action, detailed trial design, research quality, and the preparation of regulatory documents belong to their own branches.

• How a medicine is developed, stage by stage — the sequence from target and candidate through the clinical phases, pharmacokinetics and the label, and mass balance studies
• Preclinical models and what they predict — choosing cell, animal, and simulation models, their limits in predicting human results, and alternatives to animal testing
• Nonclinical safety studies — study requirements, species and dose selection, interpretation of findings, and the first dose in humans
• Biomarkers in drug development — their purposes, regulatory qualification, and identification from omics and clinical data
• What development costs, and why most candidates fail — attrition, time, costs and returns across the pipeline, and the economics of cancer drug development