Simulations Plus

Extemporaneous preparation (EP) formulation is an attractive strategy to accelerate the formulation development of new chemical entities for first entry into human study.

Drug development is expensive, time-consuming, and has a high failure rate.

A mathematical equation model was developed by building the relationship between the fu,b/fu,p ratio and the computed physicochemical properties of candidate compounds, thereby predicting Kp,uu,brain based on a single experimentally measured Kp,brain value.

Physiologically based pharmacokinetic (PBPK) modeling is a paradigm shift in this era for determining the exposure of drugs in pediatrics, geriatrics, and patients with chronic diseases where clinical trials are difficult to conduct.

Reliable estimates of drug uptake from blood to brain parenchyma are crucial in CNS drug discovery and development.

This report summarizes the proceedings for Day 1 Session 3 of the 2-day public workshop entitled “Best Practices for Utilizing Modeling Approaches to Support Generic Product Development,” a jointly sponsored workshop by the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) in the year 2022.

Safety and efficacy are the most critical factors for the development of modern medications.

Aprocitentan is a novel, potent, dual endothelin receptor antagonist that recently demonstrated efficacy in the treatment of difficult-to-treat (resistant) hypertension.

Predicting the absorption of drugs from enabling formulations is still challenging due to the limited capabilities of standard physiologically based biopharmaceutics models (PBBMs) to capture complex absorption processes.

Depressive disorders contribute to an excruciating global mental health burden.

Oxycodone is one of the most commonly used opioids to treat moderate to severe pain.

Glioblastoma multiforme (GBM) is the most common primary brain tumour in adults.