The bioequivalence of pharmaceutical formulations is typically demonstrated by assessing the pharmacokinetics (PK) of a generic product relative to a reference listed drug (RLD) product. However, for topical products applied to the skin, it has been historically challenging to quantify the drug concentration at the target site of action, and therefore the applicability of the PK-based approach has been limited. Here, we present a novel approach based on stimulated Raman scattering imaging and data processing via deep learning for image feature extraction and automated analysis of cutaneous PK parameters, which also enables the imaging of drug distribution in real time.
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