NIH-funded research U01 cooperative agreement

PBPK-based link between in vitro release and in vivo performance for PLGA implants

Official title: Developing PBPK-model based mechanistic IVIVC for PLGA implants

Funded at University of Texas at Austin · NIH-11401615 · Data updated 2026-11-12

A projects uses computer modeling to connect how a PLGA implant releases buprenorphine in the lab to how it behaves in the body, aiming to predict patient drug levels.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Texas at Austin
NIH-funded
Lab location1 site (Austin, United States)
Project startSeptember 1, 2024
Project endAugust 31, 2027
Funding year2026
Award (this year)$249,732
NIH project number5U01FD008303-03
Project IDNIH-11401615 on NIH RePORTER

Who could benefit from this research

Could help

This research is focused on implant technology; future participants would be patients who receive PLGA-based buprenorphine implants.

Less likely to help

People not receiving PLGA-based implants or not involved in pharmacokinetic studies may not benefit directly.

What this research studies

This project will create a predictive model that links labrelease data from a long-acting PLGA buprenorphine implant to real patient drug levels using physiologically based pharmacokinetics. Researchers will develop a bio-predictive in-vitro release test and identify which formulation factors most influence release. They will then build a bottom-up PBPK model to translate in-vitro results into in-vivo pharmacokinetics, helping to forecast implant performance in people.

Why it matters

Potential benefit: If successful, the work could improve the design of long-acting implants and better anticipate patient dosing needs.

How similar studies have gone: PBPK and IVIVC approaches have shown promise in prior implant and long-acting product research, but this project advances a tailored IVIVC for PLGA buprenorphine implants.

Where this research is happening

  • University of Texas at Austin
    Austin, United States
    Active

Researchers

  • Principal investigator: Zhang, Feng — University of Texas at Austin
  • Study coordinator: Zhang, Feng

Related research

Other NIH-funded projects on the same topics.

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.
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.