Measurement of fasted state gastric antral motility before and after a standard bioavailability and bioequivalence 240 mL drink of water: Validation of MRI method against concomitant perfused manometry in healthy participants
Khaled Heissam, Nichola Abrehart, Caroline L Hoad, Jeff Wright, Alex Menys, Kathryn Murray, Paul M Glover, Geoffrey Hebbard, Penny A Gowland, Jason Baker, William L Hasler, Robin C Spiller, Maura Corsetti, James G Brasseur, Bart Hens, Kerby Shedden, Joseph Dickens, Deanna M Mudie, Greg E Amidon, Gordon L Amidon Show all
PLoS One | PUBLIC LIBRARY SCIENCE | Published : 2020
OBJECTIVE: The gastrointestinal environment in which drug products need to disintegrate before the drug can dissolve and be absorbed has not been studied in detail due to limitations, especially invasiveness of existing techniques. Minimal in vivo data is available on undisturbed gastrointestinal motility to improve relevance of predictive dissolution models and in silico tools such as physiologically-based pharmacokinetic models. Recent advances in magnetic resonance imaging methods could provide novel data and insights that can be used as a reference to validate and, if necessary, optimize these models. The conventional method for measuring gastrointestinal motility is via a manometric tec..View full abstract
Awarded by U.S. Food and Drug Administration (FDA)
The authors GEA, GLA and LM received for this work a grant from the U.S. Food and Drug Administration (FDA), https://www.fda.gov/home, Contract HHSF223201510157C. This article therefore reflects the views of the authors and should not be construed to represent FDA's views or policies. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.