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Releases: Open-Systems-Pharmacology/OSP-Qualification-Reports

Version 11.2.1

26 Feb 11:21
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This release contains the OSP qualification reports. All reports are created with OSP 11 Update 2 and are available here.

Release Notes

New Qualification Reports

No new reports added

Updates

CYP3A4 DDI Qualification Report

Major updates

  • Carbamazepine added to the CYP3A4 DDI network: The interactions between carbamazepine as perpetrator and the victim drugs alprazolam, efavirenz, and midazolam are included as well as the interactions between carbamazepine as victim drug and cimetidine, efavirenz, and erythromycin as perpetrators.

Minor updates

See the release notes for CYP3A4 DDI Qualification Plan v. 1.5 for details

Version 11.2

19 Apr 13:46
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This release contains the OSP qualification reports. All reports are created with OSP 11 Update 2 and are available here.

Version 11.1

31 Jan 11:14
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This release contains the OSP qualification reports. All reports are created with OSP 11 Update 1 and are available here.

Version 11.0

23 May 07:29
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This release contains the OSP qualification reports. All reports are created with OSP 11 and are available here.

Release Notes

New Qualification Reports

CYP1A2 DDI

This qualification report evaluates the developed PBPK drug-drug interactions (DDI) models network for the ability to perform simulations with the intended purpose to predict cytochrome P450 1A2 (CYPA12)-mediated DDI.

CYP2C19 DDI

This qualification report evaluates the developed PBPK drug-drug interactions (DDI) models network for the ability to perform simulations with the intended purpose to predict cytochrome P450 2C19 (CYP2C19)-mediated DDI.

Updates

UGT DDI Qualification Report

Minor updates

Pediatric Qualification Report: CYP2C8 Ontogeny

Minor updates

  • updated reference to new OSP PK database release (v1.4)
  • minor editorial updates and bug fixes (typos, broken links)

Pediatric Qualification Report: CYP3A4 Ontogeny

Minor updates

  • updated reference to new OSP PK database release (v1.4)
  • minor editorial updates and bug fixes (typos, broken links)

Pediatric Qualification Report: GFR Ontogeny

Minor updates

  • updated reference to new OSP PK database release (v1.4)
  • minor editorial updates and bug fixes (typos, broken links)

Version 10.0.1

14 Jan 16:16
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This release contains the OSP qualification reports. All reports are created with OSP 10 and are available here.

Release Notes

CYP3A4 DDI Qualification Report

Major updates

  • Fluconazole added to DDI network: Interactions between fluconazole and midazolam, triazolam and alfentanil included.

Version 10.0

19 Oct 19:44
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This release contains the OSP qualification reports. All reports are created with OSP 10 and are available here.

Release Notes

CYP3A4 DDI Qualification Report

Major updates

Minor updates

UGT DDI Qualification Report

Minor updates

  • Fixed broken links

Pediatric Qualification Report: CYP2C8 Ontogeny

Major updates

  • Report only contains qualification of CYP2C8 ontogeny, as adult model building and evaluation of the substances used for pediatric qualification are now reported separately.

Minor updates

  • removed simulations from model snapshot that are not used for model qualification
  • updated reference to new OSP PK database release (v1.3)
  • minor editorial updates and bug fixes

Pediatric Qualification Report: CYP3A4 Ontogeny

Major updates

  • Report only contains qualification of CYP3A4 ontogeny, as adult model building and evaluation of the substances used for pediatric qualification are now reported separately.

Minor updates

  • removed simulations from model snapshot that are not used for model qualification
  • updated reference to new OSP PK database release (v1.3)
  • minor editorial updates and bug fixes

Pediatric Qualification Report: GFR Ontogeny

Major updates

  • Report only contains qualification of GFR ontogeny, as adult model building and evaluation of the substances used for pediatric qualification are now reported separately.

Minor updates

  • removed simulations from model snapshot that are not used for model qualification
  • updated reference to new OSP PK database release (v1.3)
  • minor editorial updates and bug fixes

Version 9.1.1

16 Dec 17:13
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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

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

Version 9.1

28 Jul 10:21
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Version 9.0

22 Jun 14:17
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