1. INTRODUCTION

This guideline is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline .The annex is not intended to establish new standards or to introduce new regulatory requirements .However , it shows how concepts and tools ( e . g . , design space1 ) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms .As a result , this more systematic approach could facilitate continual improvement and innovation throughout the produc lifecycle ( See ICH Q10 ) .