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This chapter examines the development of clinical and commercial formulations of amorphous dispersions. It considers the various means available to render a crystalline drug amorphous. The chapter explores the downstream ramifications of each technique, such as on the dosage forms available, and special processing and handling. It gives the high‐level strategic picture of amorphous formulation development, a process that best fits the framework of quality by design (QbD) advocated for by the FDA. The chapter reviews a detailed case study of the first amorphous dispersion‐based drugs developed and commercialized inhouse, the hepatitis C protease inhibitor VX‐950 or telaprevir (Incivek). It focuses on developing a drug product manufacturing process, including defining parameters, developing the design space, modeling, and applying the QbD framework to manufacture. The chapter examines the analytical methods used to discriminate dispersion attributes and tablet properties that could affect performance of the product in the clinic.

Abstract. On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.