Saturday, November 18, 2017

ICH Q3D Module 0 – Overview

ICH Q3D Module 0 - Overview

ICH Q3D Module 1 – Developing Acceptable Levels for Other Routes of Administration

ICH Q3D Module 1 - Developing Acceptable Levels for Other Routes of Administration

ICH Q3D Module 2 – Justification For Exceeding a PDE

ICH Q3D Module 2 - Justification For Exceeding a PDE

ICH Q3D Module 3 – Developing Acceptable Levels for EInot in Q3D

ICH Q3D Module 3 - Developing Acceptable Levels for EInot in Q3D

ICH Q3D Module 4 – Considerations For Large Volume Parenterals

ICH Q3D Module 4 - Considerations For Large Volume Parenterals

ICH Q3D Module 5 – Risk Assessment

ICH Q3D Module 5 - Risk Assessment

ICH Q3D Module 6 – Controls on Elemental Impurities

ICH Q3D Module 6 - Controls on Elemental Impurities

ICH Q3D Module 7 – Calculations Options

ICH Q3D Module 7 - Calculations Options