ABSTRACT
Sir Ronald Fisher introduced the concept of applying statistical analysis in the beginning of the twentieth century. Recently, regulatory guidelines issued by the key federal agencies to implement the practice of ‘quality by design (QbD)’ approach to the researchers in the industrial milieu, in particular, to use experimental designs during drug product development. The aim to introduce the design approach is to build quality into the product. The implementation of the QbD approach in the transdermal/topical formulation is the key enabler of assuring quality in the final product. The optimization processes are required for accurate research in these fields and therefore, the right implementation is carried out for different design approaches at an industrial scale. This chapter illustrates the principles of QbD design and their contributions to the background of the design of experiments in different transdermal/topical nanoformulations.
