ABSTRACT
This chapter focuses on the issues involved in the design of clinical trials either for proof of concept or the primary randomized trials necessary for approval. The contents are very general in nature which cover clinical trials required for any type of dosage forms including dermal. The Food and Drug Administration began its modern regulatory functions with the passage of the 1906 Pure Food and Drugs Act focused primarily on the safety and appropriate labeling of food and drugs. In addition to the usual systemic side effect, dermal delivery systems must also consider other factors including the effect of a high drug concentration on local structures, the matrix material or adhesives, the occlusion of the skin, and method used to promote delivery or enhance short-term delivery. For the drug approval process and in providing data to clinicians on how to use a treatment process, the potential risks must also be assessed.
