Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State-A Case Study

• Main Authors: Víctor Mangas-Sanjuán (Author), Marta Simón (Author), Esperanza González-Rojano (Author), Dolores Ochoa (Author), Francisco Abad-Santos (Author), Manuel Román (Author), Mercedes Ramos (Author), Carlos Govantes (Author), Alfredo García-Arieta (Author)
• Format: Book
• Published: MDPI AG, 2023-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

(1) Background: this article investigates which PK metrics in a single-dose study (concentration at the end of posology interval, C_τ, partial areas under the curve, pAUCs, or half-value duration, HVD) are more sensitive and less variable for predicting the failure of a prolong...