Systems-based Pharmaceutics (SbP) is a holistic approach to the development and optimization of drug manufacture and drug delivery. SbP applies high-fidelity mathematic models of a manufacturing process, validated against experimental data, to explore the design and operational decision space rapidly and effectively. A systems-based approach considers the entire manufacture-to-delivery system including drug substance manufacturing, drug product manufacturing, absorption, pharmacokinetics, pharmacodynamics as a single related system. The approach enables companies to make globally optimal design and operating decisions based on delivering the required key performance indicators (KPIs). SbP has the potential to transform pharmaceutical process development and design, leading to significantly accelerated development, improved R&D efficiency, reduced cost and risk and many other benefits.