Development and Bio-Predictive Evaluation of Biopharmaceutical Properties of Sustained-Release Tablets with a Novel GPR40 Agonist for a First-in-Human Clinical Trial

Development and Bio-Predictive Evaluation of Biopharmaceutical Properties of Sustained-Release Tablets with a Novel GPR40 Agonist for a First-in-Human Clinical Trial

Sustained-release (SR) formulations may appear advantageous in first-in-human (FIH) study of innovative medicines. The newly developed SR matrix tablets require prolonged maintenance of API concentration in plasma and should be reliably assessed for the risk of uncontrolled release of the drug. In t...

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Bibliographic Details
Main Authors: Ewelina Juszczyk, Kamil Kisło, Paweł Żero, Ewa Tratkiewicz, Maciej Wieczorek, Jadwiga Paszkowska, Grzegorz Banach, Marcela Wiater, Dagmara Hoc, Grzegorz Garbacz, Jaroslaw Sczodrok, Dorota Danielak
Format: Article
Language:English
Published: MDPI AG 2021-05-01
Series:Pharmaceutics
Subjects:
GPR40 agonist
sustained-release tablets
first in human clinical trials
simulation of gastrointestinal passage
biorelevant dissolution testing
stress test device
Online Access:https://www.mdpi.com/1999-4923/13/6/804

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https://www.mdpi.com/1999-4923/13/6/804

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