It is critical to develop an effective understanding of the interaction between the drug, delivery
system and skin in order to predict and assess skin penetration and permeation. Experimental models
for the assessment of topical and transdermal delivery systems must permit evaluation of these complex
interactions. Whilst in the past, animal models were commonly used, recent regulatory guidelines, based
on 3R principles (refinement, reduction, replacement), encourage the rational use of animals. Alternative
methods have been proposed for use in the development of topical and transdermal delivery systems
which are often used in combination. We will review the current state of the art in alternative methods
for topical and transdermal delivery systems development, including technologies that can assist in the
characterization of skin penetration/permeation studies.
Keywords: Skin penetration, Drug delivery systems, Alternative methods, In vivo, Ex vivo, In silico, Skin permeation.
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