Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demonstration of its ability not only in predicting formulation-dep...

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Bibliographic Details
Published in:	The AAPS journal Vol. 24; no. 1; p. 21
Main Authors:	Bego, Margareta, Patel, Nikunjkumar, Cristofoletti, Rodrigo, Rostami-Hodjegan, Amin
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 05.01.2022 Springer
Subjects:	Adolescent Adult Biochemistry Biological Availability Biomedical and Life Sciences Biomedicine Biotechnology Cross-Over Studies Delayed-Action Preparations Gastrointestinal Tract - physiology Humans Male Medical research Medicine, Experimental Middle Aged Models, Biological Pharmacology/Toxicology Pharmacy Physiological aspects Posaconazole Proof of Concept Study Research Article Research Design Theme: Integrating In Vitro Systems and Physiologically-Based Pharmacokinetics Modeling to Optimize Drug Product Development Therapeutic Equivalency Triazoles - administration & dosage Triazoles - pharmacokinetics Young Adult intra-subject variation virtual bioequivalence physiology-based pharmacokinetics within-subject variability
ISSN:	1550-7416, 1550-7416
Online Access:	Get full text
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