Module 3 - Strategic case studies in practice

Stability – follow the ICH guidelines

ICH Q1A ICH Q1B ICH Q1C ICH Q1D ICH Q1E ICH Q1F

Stability Testing of New Drug Substances and Products Photostability Testing of New Drug Substances and Products

Stability Testing for New Dosage Forms

Bracketing and Matrixing Designs for stability testing of New Drug Substances and Products

Evaluation of Stability Data

Stability data package for Climatic Zones III and IV

ICH Q5E

Stability testing of Biotechnology Products