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# FDAers Discuss PBBM Overview and Future
- URL: https://www.fdaweb.com/fdaers-discuss-pbbm-overview-and-future/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151868

Three FDAers and an AstraZeneca researcher say physiologically-based biopharmaceutics modeling (PBBM) is an evolving field and interest in using it is increasing. Writing online in *Pharmaceutical Research*, the four [say](https://link.springer.com/article/10.1007/s11095-022-03280-4?ref=fdaweb.com) that FDA has emphasized the use of patient-centric quality standards and clinically relevant drug product specifications over the years.

“Establishing an *in vitro-in vivo* link is an important step towards achieving the goal of a patient-centric quality standard,” they write. “Such a link can aid in constructing a bioequivalence safe space and establishing clinically relevant drug product specifications. PBBM is an important tool to construct a safe space that can be used during drug product development and lifecycle management.”

The article provides an overview of experience gained so far and the current perspective from the regulatory and industry points of view.

“PBBMs hold many promises for patients, regulators, and the pharmaceutical industry,” the authors conclude. “Now is the time to deliver on these.”