Abstract

ICH GUIDELINES AND MAIN FOCUS ON STABILITY GUIDELINES FOR NEW FORMULATION AND DOSAGE FORMS

Yogita Somvanshi* and Prakash Satbhai

Abstract

This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration apllication within the three regions of the European Union(EU), Japan, and the United States. It does not seek to address the testing for registration in orexport to other areas of the world. The guidance exemplifies the core stability data package fornew drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations andcharacteristics of the materials being evaluated. Alternative approaches can be used when thereare scientifically justifiable reasons.The guidance addresses the information to be submitted in registration applications for new molecular entities and associated drug products. This guidance does not currently seek to cover the information to be submitted for abbreviated or abridged applications, variations, or clinical trial applications.

Keywords: Accelerated stability, Photostability, long term stability , Bracketing , Matrixing.