Results 71 to 80 of about 1,723 (196)

Physiologically‐Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 1, January 2026.
ABSTRACT Pediatric extrapolation strategies issued by health authorities have streamlined pediatric drug development and reduced the unnecessary burden of conducting pediatric clinical studies. In line with these strategies, physiologically based pharmacokinetic (PBPK) models have been utilized extensively for initial dosing regimen and sampling ...
James W. T. Yates, Michael Zientek, Kunal S. Taskar, Wen Lin, Tycho Heimbach, Stefan Willmann, Jessica Rehmel, Neil Parrott, Michael Hanley, Justine Badee, Yuan Chen, Susan Cole, Loeckie De Zwart, Sebastian Haertter, Rongrong Jiang, Masakatsu Kotsuma, Guiqing Liang, Yu‐Wei Lin, Jing Liu, Ying Ou, Juliane Rascher, Naveed A. Shaik, Jan Wahlstrom, Xiaofeng Wang, Guangqing Xiao, Ka Lai Yee, S. Y. Amy Cheung   +26 more
wiley   +1 more source

Toward Integrative Predictive Toxicology: Advanced Methods for Drug Toxicity and Safety Prediction

WIREs Computational Molecular Science, Volume 16, Issue 1, January/February 2026.
This figure summarizes the different methods in integrative predictive toxicology reviewed in this work, ranging from exploration of molecular mechanisms to in silico pharmacokinetic modeling and construction of adverse outcome pathway (AOP) networks based on key events (KEs) and key event relationships (KERs). Further integration with multi‐omics data
Eleonora Gianquinto, Matteo Bersani, Lucrezia Armando, Lara Davani, Clara Cena, Angela De Simone, Francesca Spyrakis   +6 more
wiley   +1 more source

DISSOLUTION MEDIA USED IN DEVELOPMENT AND QUALITY CONTROL OF DRUGS

Разработка и регистрация лекарственных средств, 2019
The main dissolution media recommended for the Dissolution test in Russia and abroad are represented in the review. Possible applications of biorelevant media and media with surfactants are also shown.
O. V. Druzhininskaya, I. E. Smekhova
doaj  

On the Usefulness of Two Small-Scale In Vitro Setups in the Evaluation of Luminal Precipitation of Lipophilic Weak Bases in Early Formulation Development

Pharmaceutics, 2020
A small-scale biphasic dissolution setup and a small-scale dissolution-permeation (D-P) setup were evaluated for their usefulness in simulating the luminal precipitation of three lipophilic weak bases—dipyridamole, ketoconazole and itraconazole ...
Patrick J. O’Dwyer, Georgios Imanidis, Karl J. Box, Christos Reppas   +3 more
doaj   +1 more source

A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products

Dissolution Technologies, 2009
Biorelevant in vitro dissolution is a useful technique for qualitative forecasting of the in vivo behavior of a formulation. A biorelevant dissolution medium for simvastatin was developed with a lower concentration of surfactant (0.1% sodium lauryl sulfate, SLS) in the medium as compared with the 0.5% SLS concentration stated in the USP monograph.
N. Singla, G. D. Gupta, K. Kohli, A. K. Singla   +3 more
openaire   +1 more source

Computational and Experimental Insights into a Ferric Cumylperoxido Species Stabilized in a Bispidine Scaffold

Zeitschrift für anorganische und allgemeine Chemie, Volume 651, Issue 18, December 10, 2025.
An iron(III)‐cumylperoxido intermediate has been generated that performs electrophilic and nucleophilic reactivity under ambient conditions. Iron‐containing alkylperoxido species are mostly unstable, although these are important reactive intermediates found in metalloenzymes.
Gunasekaran Velmurugan, Gourab Mukherjee, Umesh Kumar Bagha, Chivukula V. Sastri, Peter Comba   +4 more
wiley   +1 more source

Validación de un método analítico empleando cromatografía líquida de alta eficiencia para la determinación de ibuprofeno en medios biorrelevantes Validation of an analytical method by liquid chromatography for determination of ibuprofen in biorelevant media

Química Nova, 2010
An analytical method by liquid chromatography has been proposed and validated to study the apparent solubility of ibuprofen in biorelevant dissolution media.
Sandra M. Gómez, Jorge A. Martínez, Fleming Martínez   +2 more
doaj   +1 more source

Betaine‐Conjugated ß‐Peptide Foldamers: Influence of Quaternary Charge on Self‐Organization and MorphologyFormation

ChemistryOpen, Volume 14, Issue 12, December 2025.
N‐terminal betaine conjugation modifies β‐peptide helices, influencing folding and self‐organization. For [1S, 2S]‐ACPC, folding to an H12 helix was unaffected, while [1R, 2R]‐ACHC formed an H14 helix instead of H10. Alternating heterochiral oligomers made of enantiomeric pairs of trans‐ACPC showed enhanced solubility and E‐strand formation.
Nikolett Varró, Eszter Erdei, Dóra Bogdán, Eszter Kalydi, Ruth Deme, Balázs Balogh, Imola Cs. Szigyártó, Tamás Beke‐Somfai, Zoltán Varga, Pál Szabó, István M. Mándity   +10 more
wiley   +1 more source

An Open‐Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 12, Page 1932-1948, December 2025.
ABSTRACT To establish bioequivalence (BE) of a generic test formulation with respect to a reference listed drug, it is necessary to demonstrate a comparable rate and extent to which active ingredients reach the site of action. To decrease unnecessary human testing and simulate scenarios involving specific populations or challenges with recruitment or ...
Abdullah Hamadeh, Moriah Pellowe, Pierre Chelle, Cindy Hoi Ting Yeung, Julian Otalvaro, Walter Yamada, Jay Bartroff, Alona Kryshchenko, André Dallmann, Juri Solodenko, Jörg Lippert, Eleftheria Tsakalozou, Michael Neely, Andrea Edginton   +13 more
wiley   +1 more source

Impact of HPMCAS on the Dissolution Performance of Polyvinyl Alcohol Celecoxib Amorphous Solid Dispersions

Pharmaceutics, 2020
Amorphous solid dispersions (ASDs) have been proven to increase the bioavailability of poorly soluble drugs. It is desirable that the ASD provide a rapid dissolution rate and a sufficient stabilization of the generated supersaturation. In many cases, one
Marius Monschke, Karl G. Wagner
doaj   +1 more source