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Integrating Model-Informed Drug Development With AI: A Synergistic Approach to Accelerating Pharmaceutical Innovation.
Clin Transl Sci
January 2025
Global Biometrics and Data Management, Pfizer Research and Development, New York, New York, USA.
The pharmaceutical industry constantly strives to improve drug development processes to reduce costs, increase efficiencies, and enhance therapeutic outcomes for patients. Model-Informed Drug Development (MIDD) uses mathematical models to simulate intricate processes involved in drug absorption, distribution, metabolism, and excretion, as well as pharmacokinetics and pharmacodynamics. Artificial intelligence (AI), encompassing techniques such as machine learning, deep learning, and Generative AI, offers powerful tools and algorithms to efficiently identify meaningful patterns, correlations, and drug-target interactions from big data, enabling more accurate predictions and novel hypothesis generation.
View Article and Find Full Text PDFNew Insights Into Hepatic Impairment (HI) Trials.
Clin Transl Sci
January 2025
Clinical Pharmacology, Translational Medicine and Clinical Pharmacology, Boehringer-Ingelheim Pharma, Ingelheim, Germany.
Hepatic impairment (HI) trials are traditionally part of the clinical pharmacology development to assess the need for dose adaptation in people with impaired metabolic capacity due to their diseased liver. This review aimed at looking into the data from dedicated HI studies, cluster these data into various categories and connect the effect by HI with reported pharmacokinetics (PK) properties in order to identify patterns that may allow waiver, extrapolations, or adapted HI study designs. Based on a ratio ≥ 2 or ≤ 0.
View Article and Find Full Text PDFCharacterization and Biomedical Applications of Electrospun PHBV Scaffolds Derived from Organic Residues.
Int J Mol Sci
December 2024
Department of Chemical Engineering, Barcelona East School of Engineering (EEBE), Polytechnic University of Catalonia, Av. Eduard Maristany, 10-14, Ed. I2, 08019 Barcelona, Spain.
This study explores the characterization and application of poly(3-hydroxybutyrate--3-hydroxyvalerate) (PHBV) synthesized from organic residues, specifically milk and molasses. Six PHBV samples with varying 3-hydroxyvalerate (3HV) content (7%, 15%, and 32%) were analyzed to assess how 3HV composition influences their properties. Comprehensive characterization techniques, including NMR, FTIR, XRD, DSC, TGA, and tensile-stress test, were used to evaluate the molecular structure, thermal properties, crystalline structure, and mechanical behavior.
View Article and Find Full Text PDFUnderstanding Microemulsions and Nanoemulsions in (Trans)Dermal Delivery.
AAPS PharmSciTech
January 2025
Consulting, Fort Collins, Colorado, USA.
Continuously explored in pharmaceuticals, microemulsions and nanoemulsions offer drug delivery opportunities that are too significant to ignore, namely safe delivery of clinically relevant drug doses across biological membranes. Their effectiveness as drug vehicles in mucosal and (trans)dermal delivery is evident from the volume of published literature. Commonly, their ability to enhance skin permeation is attributed to dispersion size, a characteristic closely related to solubilization capacity.
View Article and Find Full Text PDFDigiLoCS: A leap forward in predictive organ-on-chip simulations.
PLoS One
January 2025
ESQlabs Gmbh, Saterland, Germany.
Digital twins, driven by data and mathematical modelling, have emerged as powerful tools for simulating complex biological systems. In this work, we focus on modelling the clearance on a liver-on-chip as a digital twin that closely mimics the clearance functionality of the human liver. Our approach involves the creation of a compartmental physiological model of the liver using ordinary differential equations (ODEs) to estimate pharmacokinetic (PK) parameters related to on-chip liver clearance.
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