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The Formulation Design and Development (FDD) section is comprised of members from 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 the FDD 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 for drug, biologic, and drug/biologic device combinations, and over-the-counter products.

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 product development includes evaluation of dosage form manufacturability, stability, quality and performance both in vitro and in vivo that is appropriate for its development stage.