Recent breakthroughs in artificial intelligence (AI) and machine learning (ML) have ushered
in a new era of possibilities across various scientific domains. One area where these …

Rare diseases, affecting millions globally, present significant drug development challenges.
This is due to the limited patient populations and the unique pathophysiology of these …

PBPK applications published in the literature support a greater adoption of non‐open source‐
code (NOSC) software as opposed to open source‐code (OSC) alternatives. However, a …

This review examines the role of model-informed drug development (MIDD) in advancing
antibacterial and antiviral drug development, with an emphasis on the inclusion of host …

Abstract 2023 marks the 10th anniversary of Natpara's submission to the US FDA, which led
to the first recorded regulatory interaction where a decision was supported by Quantitative …

A recent industry perspective published in this journal describes the benefits received by
drug companies from participation in the MIDD Pilot Program. Along with the primary …

Valproic acid (VPA) is a short-chain fatty acid widely prescribed in the treatment of seizure
disorders and epilepsy syndromes, although its therapeutic value may be undermined by its …

Propylthiouracil (PTU) and methimazole (MMI), two classical antithyroid agents possess risk
of drug-induced liver injury (DILI) with unknown mechanism of action. This study aimed to …

Abstract Quantitative Systems Pharmacology (QSP) models are increasingly being applied
for target discovery and dose selection in immuno-oncology (IO). Typical application …

The quantitative systems pharmacology (QSP) approach is widely applied to address
various essential questions in drug discovery and development, such as identification of the …