Using an In Vitro-In Vivo Correlation for the ‘Bioequivalence by Design’ Development of an Immediate Release Carbamazepine Product [PDF]
The quality of a drug product may be characterized by the consistency with which its indicated clinical effect, and safety profile, is experienced by the patient.
Steinbach, Douglas
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Background: Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications.
Loisios-Konstantinidis, Ioannis +4 more
openaire +1 more source
In silico prediction of bioequivalence of atorvastatin tablets based on GastroPlus™ software. [PDF]
Wang L +6 more
europepmc +1 more source
Effectiveness of virtual simulation-based pre-learning and the mediating role of metacognition in pharmacokinetics laboratory education. [PDF]
Hu X, Liu J, Wang J.
europepmc +1 more source
Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study. [PDF]
García MA +3 more
europepmc +1 more source
Computer Simulations as a Tool for Optimizing Bioequivalence Trials [PDF]
Alfredo García-Arieta +6 more
core +1 more source
Physiologically based pharmacokinetic modelling to guide drug delivery in older people [PDF]
core +1 more source
Development of in vitro-in vivo correlation for establishing patient-centric quality standards of dissolution for lamotrigine extended-release tablets. [PDF]
Zidan A +5 more
europepmc +1 more source
Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling. [PDF]
Telaprolu KC +8 more
europepmc +1 more source

