Innovative Approaches in Skin Formulation Development and Characterization: Scientific Foundations for Regulatory Transformation

Dear Colleagues,

In the era of generative artificial intelligence (AI), which was welcomed by certain drug regulatory agencies, it is reasonable to expect accelerated implementation of all research innovations. Ranging from innovative pharmaceutical formulations (often being nanostructured) to sophisticated physico-chemical, thermal, imaging ,or analytical characterization techniques, even more conservative regulators could be convinced to implement certain changes in the existing guidelines and processes. Currently, a formulation’s nano/microstructure can be fully characterized using a smart set of complementary techniques. However, availability and equivalence testing often rely on human volunteers and/or excised human skin. On one hand, studies with clinical endpoints are faced with well-known assessment challenges. On the other hand, excised human skin introduces a number of variabilities (loss of physiological functions; donor-, storage-, or handling-related artifacts; etc.). Reputable research groups place great effort into developing skin models, such as reconstructed human epidermis (RHE), full-thickness models, and advanced 3D bioprinted constructs. Although they require further improvement in order to serve as true substitutes for human skin, their human-relevant biology, customizability to certain diseases, and compatibility with imaging and analytics offer rapid screening. Finally, upon robust validation, in silico models are continually improved to better support in vitro data, thereby aiming to reduce and potentially replace the need for human volunteers.

This Special Issue aims to encourage researchers to publish their findings in the field of topical and transdermal drug delivery systems. This Special Issue could enhance the available body of data for scientific justification of regulatory-driven skin formulation development.

We look forward to receiving your contributions.

Prof. Dr. Snezana Savic
Dr. Ivana Pantelić
Guest Editors

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