NIH-funded research U01 cooperative agreement

Creating a virtual platform to simulate drug equivalence for better treatment options

Official title: A State-of-the-Art Virtual Bioequivalence Platform and Case Studies on Complex Formulations, Systemic and Local Concentration-based Bioequivalence

Funded at Certara UK Limited · NIH-10913489 · Data updated 2026-11-12

This study is working on a new computer program that can mimic how different versions of medications work in the body, which could help make drug testing safer and cheaper for patients by reducing the need for traditional clinical trials.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionCertara UK Limited
NIH-funded
Lab location1 site (Sheffield, United Kingdom)
Project startJuly 3, 2023
Project endJuly 2, 2026
Funding year2024
Award (this year)$249,837
NIH project number5U01FD007904-02
Project IDNIH-10913489 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates for this research are patients who are involved in or affected by the development of new drug formulations.

Less likely to help

Patients who are not participating in drug development or who are not affected by the specific formulations being tested may not benefit from this research.

What this research studies

This research focuses on developing a virtual bioequivalence (VBE) platform that uses advanced computer modeling to simulate how different drug formulations behave in the body. By creating realistic virtual patient cohorts, the platform aims to replace traditional clinical trials, which can be costly and expose patients to unnecessary treatments. The project will establish clear workflows and case studies to ensure that this innovative approach is widely adopted by the pharmaceutical industry and regulatory bodies, ultimately improving drug development processes.

Why it matters

Potential benefit: If successful, this research could significantly speed up drug development and provide safer, more effective treatment options for patients.

How similar studies have gone: Other research has shown promise in using virtual simulations for drug development, indicating that this approach could lead to significant advancements in the field.

Where this research is happening

  • Certara UK Limited
    Sheffield, United Kingdom
    Active

Researchers

  • Principal investigator: Bois, Frederic — Certara UK Limited
  • Study coordinator: Bois, Frederic

Related research

Other NIH-funded projects on the same topics.

  • Improving how topical drugs are formulated and absorbed through the skin

    This study is looking at how well skin creams and ointments work by using special computer models to see how different people absorb the medicine through their skin, so we can make sure these products are safe and effective for everyone.

    NIH research Certara UK Limited · Sheffield, United Kingdom · NIH-10908460

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.