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This chapter explores the intersection of clinical trials and regulatory approval processes within the burgeoning field of 3D-printed pharmaceuticals (3D-PPs). As 3D-printing (3D-P) technology continues to evolve, its applications in pharmaceuticals offer promises of personalized medicine, enhanced drug delivery systems, and streamlined manufacturing processes. However, navigating the complex landscape of clinical trials and regulatory frameworks poses significant challenges. This chapter provides a comprehensive review of the status, challenges, and prospects of conducting clinical trials and obtaining regulatory approvals for 3D-PPs. It addresses key considerations such as regulatory requirements, quality control standards, patient safety, and efficacy assessment methodologies. Furthermore, it discusses emerging trends, regulatory updates, and potential strategies to facilitate the successful translation of 3D-PPs from bench to bedside.

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Clinical Trials and Regulatory Approval of 3D-Printed Pharmaceuticals

  • 章节

  • 发表日期：

    2025年

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  • Bannimath Gurupadayya,
  • Meghraj Suryawanshi,
  • Aparna Inamdar,
  • Parashuram Bugadannavar,
  • Arushi,
  • Himanshu Sharma,
  • Pranjal Gujarathi,
  • Kuldeep Vinchurkar

摘要

This chapter explores the intersection of clinical trials and regulatory approval processes within the burgeoning field of 3D-printed pharmaceuticals (3D-PPs). As 3D-printing (3D-P) technology continues to evolve, its applications in pharmaceuticals offer promises of personalized medicine, enhanced drug delivery systems, and streamlined manufacturing processes. However, navigating the complex landscape of clinical trials and regulatory frameworks poses significant challenges. This chapter provides a comprehensive review of the status, challenges, and prospects of conducting clinical trials and obtaining regulatory approvals for 3D-PPs. It addresses key considerations such as regulatory requirements, quality control standards, patient safety, and efficacy assessment methodologies. Furthermore, it discusses emerging trends, regulatory updates, and potential strategies to facilitate the successful translation of 3D-PPs from bench to bedside.