Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

In the era of precision medicine, digital technologies and artificial intelligence, drug
discovery and development face unprecedented opportunities for product and business …

Model‐informed drug development (MIDD) refers to the application of a wide range of
quantitative models in drug development to facilitate the decision‐making process. MIDD …

Pharmacokinetic/pharmacodynamic (PK/PD) analysis has proved to be very useful to
establish rational dosage regimens of antimicrobial agents in human and veterinary …

Abstract The International Council for Harmonisation revised the E14 guideline through the
questions and answers process to allow concentration-QTc (C-QTc) modeling to be used as …

In the last decades three-dimensional (3D) in vitro cancer models have been proposed as a
bridge between bidimensional (2D) cell cultures and in vivo animal models, the gold …

The value of in silico methods in drug development and evaluation has been demonstrated
repeatedly and convincingly. While their benefits are now unanimously recognized …

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 …

Intravitreal administration of anti-vascular endothelial growth factor (VEGF) antibodies has
become the standard treatment for Age-Related Macular Degeneration; however, the …

Modeling and simulation emerges as a fundamental asset of drug development. Mechanistic
modeling builds upon its strength to integrate various data to represent a detailed structural …