Results 41 to 50 of about 690 (120)

On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet

Pharmaceutics, 2021
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro ...
Varun Kushwah, Sumit Arora, Miklós Tamás Katona, Dattatray Modhave, Eleonore Fröhlich, Amrit Paudel   +5 more
doaj   +1 more source

In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone

Pharmaceutics, 2021
Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is ...
Elena M. Tosca, Maurizio Rocchetti, Elena Pérez, Conchi Nieto, Paolo Bettica, Jaime Moscoso del Prado, Paolo Magni, Giuseppe De Nicolao   +7 more
doaj   +1 more source

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Pharmacology &Therapeutics, EarlyView.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix, Sam Mostafa, Amin Rostami‐Hodjegan, Thomas M. Polasek, Carl M. J. Kirkpatrick   +4 more
wiley   +1 more source

Virtual Twin Approach Using Physiologically Based Pharmacokinetic Modeling to Support Precision Dosing of Valproic Acid in Geriatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Personalized dosing is particularly important for drugs with narrow therapeutic indices in geriatric patients, who exhibit substantial physiological variability and limited pharmacokinetic (PK) evidence to guide individualized dose selection. Valproic acid (VPA) is an effective treatment option for bipolar disorder in older adults, yet dosing largely ...
Yoo Jin Jang, Dong‐Gyu Heo, Eunjin Hong   +2 more
wiley   +1 more source

Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 435-447, March 2025.
Abstract Intranasal diamorphine (IND), approved for managing breakthrough pain in the UK, has been identified as an acceptable alternative offering effective, expedient, and less traumatic analgesia for children. However, the current dose regimen in pediatric populations relies on clinical expertise while the pharmacokinetics properties are poorly ...
Lianjin Cai, Jingchen Zhai, Beihong Ji, Fengyang Han, Taoyu Niu, Luxuan Wang, Junmei Wang   +6 more
wiley   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Virtual Bioequivalence Frameworks and Workflows

We are developing advanced virtual bioequivalence (VBE) assessment models and methods, with a focus on the fundamentals of decision workflows in that context.This presentation covers: VBE workflows Advanced long-acting injectable and oral absorption models Case studies overview Software ...
openaire   +3 more sources

Photoacoustic Microscopy for Multiscale Biological System Visualization and Clinical Translation

Advanced Science, Volume 13, Issue 9, 13 February 2026.
Photoacoustic microscopy (PAM) is a powerful biomedical imaging tool renowned for its non‐invasiveness and high resolution. This review synthesizes recent technological advances and highlights their broad applications from cellular and organ‐level to whole‐animal imaging.
Tingting Wang, Jiali Chen, Liming Nie, Honghui Li   +3 more
wiley   +1 more source

Mechanism‐Based Predictions of Local Tissue and Systemic Exposure for Drug Products Delivered Through the Female Reproductive Tract

The Journal of Clinical Pharmacology, Volume 66, Issue 2, February 2026.
Abstract Effective drug delivery through the female reproductive tract (FRT) presents unique challenges due to the lack of robust predictive models for drug exposure via this route. Addressing this gap, we developed and evaluated a comprehensive whole‐body physiologically based pharmacokinetic (PBPK) model that incorporates anatomical and physiological
Xinnong Li, Thomas Straubinger, Lisa C. Rohan, Sharon L. Achilles, Beatrice A. Chen, Guru Valicherla, Zhongfang Zhang, Mark Donnelly, Eleftheria Tsakalozou, Liang Zhao, Robert Bies   +10 more
wiley   +1 more source