Simulations Plus

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.

Fluoroquinolones are broad-spectrum antibiotics that accumulate in the environment.

Evidence shows that there is an increasing use of modeling and simulation to support product development and approval for complex generic drug products in the USA, which includes the use of mechanistic modeling and model-integrated evidence (MIE).

The study aimed to evaluate the potential of piperidine-based 2H chromen-2-one derivatives against targeted enzymes, i.e., cholinesterase’s and monoamine oxidase enzymes.

Oligoadenylate synthetases (OAS) are a family of interferon (IFN)-stimulated genes known to inhibit viral replication through the enzymatic synthesis of 2'-5' oligoadenylates and activation of Ribonuclease L.

The pharmacokinetic (PK) and toxicokinetic profile of a drug from its preclinical evaluation helps the researcher determine whether the drug should be tested in humans based on its safety and toxicity.