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Abstract : The stability data package for a new drug substance or drug product that is required for an application for registration within the three regions of the EC, Japan, and the US is defined by the ICH Q1A guideline. It does not necessary aim to encompass testing for export or registration in other parts of the world. The guideline aims to provide an example of the essential stability data package for novel therapeutic substances and products, while also allowing for a wide range of possible practical situations that may arise due to particular scientific considerations and properties of the materials under evaluation. If there are reasons that can be supported by science, alternative methods can be applied.