Title : Design of Experiment for Injectable Drug Products
Abstract:
In recent years, injectable dermal fillers have challenged the use of more invasive aesthetic surgical procedures. Based on a survey conducted by the International Society of Aesthetic Plastic Surgery, there were more than 19 million nonsurgical procedures performed worldwide in 2023, where the top two most popular nonsurgical procedures were botulinum toxin and hyaluronic acid fillers. Design of experiments (DoE) is a widely used statistical tool for planning experiments, collecting and analyzing data, and drawing valid conclusions. This paper will describe the basics of DoE, types of DoE designs, and rationale for the selection of a design. Applications of DoE in the development of pharmaceutical drug products will be discussed with an emphasis on injectable drug products.