Getting the dose right is a critical but complex step in drug development. Unfortunately, this critical problem is often not sufficiently addressed. Failure rates for drugs that have progressed to Phases II and III are 40% and 50%, respectively.

This white paper describes a number of challenges with traditional dose-finding approaches and introduces key attributes of pharmacometrics, also called “model-based drug development.” Pharmacometrics in an interdisciplinary science that includes predictive quantitative modeling and analysis of pharmacology, disease and trial characteristics to improve drug development and regulatory decision-making.

Included in this white paper are specific and timely examples of the strategic impact of modeling and simulation to optimize dosage regimen, clinical trial designs, and key program decisions.

• Impact of Pharmacometric Reviews at FDA
• Pfizer’s Initiative to Reduce the Frequency and Cost of Late-Stage Failures
• Pharsight Consulting Case Study: How Modeling and Simulation Supported Dose Justification and Post-Approval Commitment for a Sponsor’s Oncology Drug

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