Limits of Detection of Topically Applied Products in the Skin Using In Vivo Raman Spectroscopy.

Autor: Nico C; RiverD International B.V., 3029 AK Rotterdam, The Netherlands., Bakker Schut TC; RiverD International B.V., 3029 AK Rotterdam, The Netherlands.; Center for Optical Diagnostics and Therapy, Department of Dermatology, Erasmus MC, University Medical Center, 3015 CN Rotterdam, The Netherlands., Caspers PJ; RiverD International B.V., 3029 AK Rotterdam, The Netherlands.; Center for Optical Diagnostics and Therapy, Department of Dermatology, Erasmus MC, University Medical Center, 3015 CN Rotterdam, The Netherlands., Puppels GJ; RiverD International B.V., 3029 AK Rotterdam, The Netherlands.; Center for Optical Diagnostics and Therapy, Department of Dermatology, Erasmus MC, University Medical Center, 3015 CN Rotterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Pharmaceutics [Pharmaceutics] 2024 Feb 22; Vol. 16 (3). Date of Electronic Publication: 2024 Feb 22.
DOI: 10.3390/pharmaceutics16030304
Abstrakt: We have developed a method to determine the limit of detection (LoD) for quantitative measurement of exogenous analytes in the outer layer of the human skin by in vivo confocal Raman spectroscopy. The method is in accordance with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use that have been adopted by regulatory authorities such as the American Food and Drug Administration and the European Medicines Agency. The method can be applied in silico so that the limit of detection can be assessed before starting a skin penetration study, for example, in areas of pharmaceutical formulation, pharmacokinetics, or toxicokinetics. This can significantly reduce the need for expensive and time-consuming feasibility studies. This paper describes the method to calculate this LoD as well as the experimental and methodological factors that can influence the calculation of the LoD.
Databáze: MEDLINE
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