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