HPE Drug stability: What do we need to know? | Page 2

CONTENTS Introduction 3 Stable or not stable – the question in good preparation practice Irene Krämer Basics 4 Drug stability: the basics Manisha Prajapati and Thorsteinn Loftsson 8 In practice In-use stability studies: an important added value Alain Astier 12 Study design Recommendations and design quality for stability studies Marta Trojniak Sources 16 Where to find extended stability data? Elise D’Huart and Jean Vigneron Outcomes 19 How extending shelf lives impacts on daily working Mark Santillo Checklist 22 Manufacturer data: considerations for provision and interpretation Robert Terkola Data evaluation 26 Evaluating stability data: a summary Graham Sewell Content Director, Secondary Care Andrea Porter Art Director James Depree Executive Director Edward Burkle