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

ABSTRACT: (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 prolonged-release product at steady-state that was the bioequivalent for C_max, AUC_0-t and AUC_0-inf, in the single-dose study; (2) Methods: a cross-over study was performed in 36 subjects receiving desvenlafaxine 100 mg prolonged-release tablets. Conventional (C_max, AUC_0-t and AUC_0-inf) and additional (C_τ, pAUCs and HVD) PK metrics were considered after single-dose conditions. Predicted PK metrics at steady state (AUC_0-τ, C

SUBMITTER: Mangas-Sanjuan V 

PROVIDER: S-EPMC9963605 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature