Version 9.1.1

This release contains the OSP qualification reports.
The qualification reports of this release are created with OSP 9.1 and are available here.

Release Notes

Notes are listed below for new or updated qualification reports. All other qualification reports are unchanged compared to previous release.

CYP3A4 DDI Qualification Report

Major updates

• Cimetidine (v1.0) included with DDIs between cimetidine and alfentanil, alprazolam, midazolam, triazolam and verapamil
• Rifampicin / verapamil DDI added (Barbarash 1988)

Minor updates

• updated references to updated releases of mother repositories for Alfentanil (v2.1), Clarithromycin (v1.1), Erythromycin (v1.1), Fluvoxamine (v1.1), Itraconazole (v1.2), Rifampicin (v1.1) and Verapamil (v1.1)
• updated references to updated released of all former DDI repositories, e.g. Rifampicin-Midazolam-DDI etc. due to optimized simulation time resolutions in snapshots
• updated reference to new OSP PK database release (v1.1)
• minor editorial updates and bug fixes

Pediatric Qualification Report: CYP2C8 Ontogeny

Fixed broken link in the introduction section

Pediatric Qualification Report: CYP3A4 Ontogeny

Fixed broken link in the introduction section

Pediatric Qualification Report: GFR Ontogeny

Fixed broken link in the introduction section