Use of Artificial Intelligence to Improve the Calculation of Percent Adhesion for Transdermal and Topical Delivery Systems.

Adhesion is a critical quality attribute and performance characteristic for transdermal and topical delivery systems (TDS). Regulatory agencies recommend in vivo skin adhesion studies to support the approval of TDS in both new drug applications and abbreviated new drug applications. The current asse...

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Publicado en:Journal of Medical Systems Vol. 48; no. 1; pp. 1 - 9
Autores principales: Wang, Chao, Strasinger, Caroline, Weng, Yu-Ting, Zhao, Xutong
Formato: equations & formulas pictorial research Journal Article
Publicado: Springer Nature 12/18/2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 12/18/2023
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s10916-023-02027-x
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        atl: Use of Artificial Intelligence to Improve the Calculation of Percent Adhesion for Transdermal and Topical Delivery Systems.
      aug:
        au:
          Wang, Chao
          Strasinger, Caroline
          Weng, Yu-Ting
          Zhao, Xutong
        affil: Food and Drug Administration, Silver Spring, Maryland, USA
      sug:
        subj:
          Artificial Intelligence Utilization
          Mobile Applications Utilization
          Photography
          Image Processing, Computer Assisted
          Drug Delivery Systems Methods
          Human
          Administration, Transcutaneous
          Administration, Topical
          Deep Learning
          Imaging, Three-Dimensional
          Skin
          Funding Source
      ab: Adhesion is a critical quality attribute and performance characteristic for transdermal and topical delivery systems (TDS). Regulatory agencies recommend in vivo skin adhesion studies to support the approval of TDS in both new drug applications and abbreviated new drug applications. The current assessment approach in such studies is based on the visual observation of the percent adhesion, defined as the ratio of the area of TDS attached to the skin to the total area of the TDS. Visually estimated percent adhesion by trained clinicians or trial participants creates variability and bias. In addition, trial participants are typically confined to clinical centers during the entire product wear period, which may lead to challenges when translating adhesion performance to the real world setting. In this work we propose to use artificial intelligence and mobile technologies to aid and automate the collection of photographic evidence and estimation of percent adhesion. We trained state-of-art deep learning models with advanced techniques and in-house curated data. Results indicate good performance from the trained models and the potential use of such models in clinical practice is further explored.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        pictorial
        research
        Journal Article
      ougenre: Article
    language: English
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