Modified release dosage forms are often designed to maximize a therapeutic effect or minimize side effects to achieve the Quality Target Product Profile (QTPP). Design and development of these dosage forms is focused on meeting the target product performance in the patient, and therefore they are well-suited to the science and risk-based approaches under Quality by Design paradigm. Papers concerning modified release dosage forms, including combination products, are being considered in this session. Submissions that address the unique challenges in designing and developing modified release dosage forms, including advances in measurement tools, and modeling, are welcome.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Pharmaceuticals (15b)