Case studies

Developing new formulations guided by a MIDD program – integrating PBPK-PBBM

Pharmetheus — Tue, 01 Sep 2026 14:35:45 GMT

Addressing formulation challenges

New or additional formulations for drugs often need to be developed for a variety of reasons, such as to improve patient compliance (e.g., fewer doses, easier administration), reduce side effects, enhance drug stability, or increase bioavailability. During this process, common issues can include poor solubility, low permeability, and variable absorption, making predicting in vivo performance difficult.

PBPK modeling of drug-drug interaction in a regulatory submission

Pharmetheus — Thu, 27 Aug 2026 16:06:08 GMT

Case

In this case study, a Pharmetheus embedded scientist applied PBPK modeling to address questions of interest in the clinical development of brigimadlin, a candidate drug targeting dedifferentiated liposarcoma. Brigimadlin presented unique challenges in predicting its behavior both as a DDI object and precipitant. The chosen middle-out PBPK modeling strategy involved integrating physicochemical properties and in vitro data, model refinement by leveraging clinical data, model qualification by reproducing published DDI outcomes, and simulations to predict brigimadlin’s potential DDI risks.

The PBPK model accurately predicted brigimadlin’s pharmacokinetics across dosing regimens and DDI scenarios. The prospective simulations successfully addressed the uncertainty of the DDI risks of complex enzyme–transporter interactions, crucial for regulatory submission. In summary, Pharmetheus’s modeling effort delivered the mechanistic clarity needed for regulatory confidence.

Optimizing CAR-T cell exposure

Pharmetheus — Thu, 13 Jun 2024 10:00:00 GMT

About the case

Therapeutic area: Oncology
Phase I — III
Impact: Informing

Model-informed microarray patches design for anti-retroviral drugs to treat children with HIV

Pharmetheus — Mon, 19 Jun 2023 10:00:00 GMT

About the case

Therapeutic area: Infectious disease

Crovalimab dose justification based on Phase 3 data in paroxysomal nocturnal hemoglobinurea patients

Pharmetheus — Mon, 19 Jun 2023 10:00:00 GMT

About the case

Therapeutic area: Blood diseases/Rare diseases
Phase III
Impact of Model Informed Drug development: Describing