Database for observed data version 1.9

What's Changed

🎯 Overview

This update implements critical modifications to the observational datasets and Drug-Drug Interaction (DDI) records. The changes primarily focus on ensuring data and simulation compatibility to successfully integrate the current Verapamil model into the CYP3A4 DDI qualification.

🚀 Key Changes & Improvements

⏱️ Time-Shifting & Dosing Adjustments

To make simulation and observed data directly compatible, time shifts and alignment corrections were applied to PK profiles, AUC calculation times, and dosing information:

• Adjusted parameters for Studies 2056, 2057, 2058, 16109, and 16110 (among others).
• Updated the victim drug observation time windows (T-min / T-max adjustments) across several studies in the DDI registry:
  • Wang 2005 (ID 1111): T-max updated to inf (from 24h).
  • Barbarash 1988 (IDs 2056, 2058): Corrected MD OD duration to 15 days and updated victim start times.
  • Abernethy 1985, Mikus 1990, Wing 1985 (IDs 16149–16156): Standardized start times (T-min) to 0 for baseline alignment.

📊 Dataset Additions

• Arithmetic SD: Added missing arithmetic standard deviation (SD) data to the PK profiles for Studies 1107 & 1108.
• Urine PK Data: Incorporated new urine PK data specifically for the Cimetidine-Verapamil DDI study (IDs 17236 & 17237).
• Project Metadata: Appended relevant project associations to the project listings for several datasets to improve organization.

🛠️ Corrections & Refinements

• LLOQ Adjustments: Corrected the Lower Limit of Quantification (LLOQ) values within the PK profiles for Studies 1328 & 1330.
• Dose Formatting: Fixed a formatting issue for Paroxetine dosing entries in the Stout 2011 studies (IDs 17116 & 17118), changing 10/10/2010 to 10.10.2010.

Full Changelog: v1.8...v1.9