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

• Main Authors: Ewelina Juszczyk (Author), Kamil Kisło (Author), Paweł Żero (Author), Ewa Tratkiewicz (Author), Maciej Wieczorek (Author), Jadwiga Paszkowska (Author), Grzegorz Banach (Author), Marcela Wiater (Author), Dagmara Hoc (Author), Grzegorz Garbacz (Author), Jaroslaw Sczodrok (Author), Dorota Danielak (Author)
• Format: Book
• Published: MDPI AG, 2021-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...