The pharmaceutical industry has recognized the value of implementing a systematic approach to drug product development where quality is built into the product and process. The FDA initiative on quality by design (QbD) promotes the design of the product and manufacturing process using principles of chemistry, engineering, material science, and quality assurance to ensure acceptable and reproducible product quality and performance throughout a product’s lifecycle. Product quality is achieved through design of robust processes that are controlled and optimized using product and process knowledge (1, 2). In the QbD paradigm, mathematical models can potentially be used at every stage of drug product development and manufacturing (3). Modeling can help establish a predictive framework using experimental data and scientific principles to create mathematical representations of the system. Predictive models aid process design by evaluating the impact that operations, equipment, and inputs have on product attributes in silico. Predictive models also provide a framework for risk assessment, process control, and optimization, where accurate predictions of the system are required

• Rutgers, The State University of New Jersey

• Oral solid dose
• Modeling

1. design of control strategy
2. Flowsheet modeling
3. modeling
4. Opinion
5. oral solid dose
6. Quality by Design (QbD)