OSD

Traditional clinical endpoint studies for topical drug products can be slow, costly and variable, creating challenges for companies developing generic and locally acting dermatological therapies. As FDA and EMA expectations around IVPT continue to evolve, robust permeation testing strategies are becoming increasingly important for supporting bioequivalence assessment and regulatory submissions. 

In this white paper, we explore how IVPT methodologies, including partial and full volume replacement techniques, can support reliable permeation data and improved reproducibility for topical products. The paper examines key considerations for IVPT method development, regulatory expectations and practical approaches to generating robust permeation profiles for topical and dermatological formulations. 

What you’ll explore 

  • How IVPT supports bioequivalence assessment for topical drug products
  • Key differences between partial and full volume replacement techniques
  • Critical factors influencing IVPT data reliability and reproducibility
  • Regulatory considerations aligned with evolving FDA and EMA guidance
  • Practical considerations for IVPT method development and optimisation
  • A case study demonstrating IVPT application in a topical gel formulation