The Formulation Design & Development (FDD) section is comprised of members from many diverse backgrounds in industry, regulatory, and academia who share a common interest in the area of formulation design, research, and development—a multidisciplinary field drawing upon the physical, chemical, biological, and engineering sciences. The primary goal of this section is to unite multiple scientific disciplines in a forum where they can share experimental results, consider new formulation and dosage form technologies, and discuss issues and concerns regarding the design and development of formulations/drug products for all dosage forms. This section collaboratively interfaces with other sections which focus on preformulation, biopharmaceutics, formulation strategies, and manufacturing process optimization.
Aspects of formulation design and development include the study of dosage forms for drug delivery via all routes of administration wherein the dosage form encompasses the formulation, process by which it is made, and primary packaging. The section’s focus on development includes product design, delivery systems and technology, stability, quality, and performance both in vitro and in vivo that is appropriate to its development stage.