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Optical Methods for Non-Invasive Determination of Skin Penetration: Current Trends, Advances, Possibilities, Prospects, and Translation into In Vivo Human Studies
 
 
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Article

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

by
Cláudio Nico
1,*,
Tom C. Bakker Schut
1,2,
Peter J. Caspers
1,2 and
Gerwin J. Puppels
1,2
1
RiverD International B.V., 3029 AK Rotterdam, The Netherlands
2
Center for Optical Diagnostics and Therapy, Department of Dermatology, Erasmus MC, University Medical Center, 3015 CN Rotterdam, The Netherlands
*
Author to whom correspondence should be addressed.
Pharmaceutics 2024, 16(3), 304; https://doi.org/10.3390/pharmaceutics16030304
Submission received: 14 December 2023 / Revised: 12 February 2024 / Accepted: 18 February 2024 / Published: 22 February 2024

Abstract

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.
Keywords: stratum corneum; human; non-invasive; quantitative; in vivo; limit of detection stratum corneum; human; non-invasive; quantitative; in vivo; limit of detection
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MDPI and ACS Style

Nico, C.; Bakker Schut, T.C.; Caspers, P.J.; Puppels, G.J. Limits of Detection of Topically Applied Products in the Skin Using In Vivo Raman Spectroscopy. Pharmaceutics 2024, 16, 304. https://doi.org/10.3390/pharmaceutics16030304

AMA Style

Nico C, Bakker Schut TC, Caspers PJ, Puppels GJ. Limits of Detection of Topically Applied Products in the Skin Using In Vivo Raman Spectroscopy. Pharmaceutics. 2024; 16(3):304. https://doi.org/10.3390/pharmaceutics16030304

Chicago/Turabian Style

Nico, Cláudio, Tom C. Bakker Schut, Peter J. Caspers, and Gerwin J. Puppels. 2024. "Limits of Detection of Topically Applied Products in the Skin Using In Vivo Raman Spectroscopy" Pharmaceutics 16, no. 3: 304. https://doi.org/10.3390/pharmaceutics16030304

APA Style

Nico, C., Bakker Schut, T. C., Caspers, P. J., & Puppels, G. J. (2024). Limits of Detection of Topically Applied Products in the Skin Using In Vivo Raman Spectroscopy. Pharmaceutics, 16(3), 304. https://doi.org/10.3390/pharmaceutics16030304

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