Introduction

Abstract

The abbreviated impactor measurement (AIM) and efficient data analysis (EDA) concepts for the in vitro assessment of orally inhaled drug products (OIPs), comprising pressurized metered-dose inhalers (MDIs), soft mist inhalers (SMIs), dry powder inhalers (DPIs), and nebulizing systems, are the topics covered by this book. The chief aims are to provide to potential adoptees of these new methods answers to how to questions, as well as to those charged with regulatory oversight assurance that both concepts are fully founded on valid scientific principles. A -chapter reviewing the cascade impaction method applied to the assessment of OIPs is also included in order to provide the reader with the necessary background material before exploring the extensions to current methodologies associated with AIM and EDA. Both concepts are related, but do not necessarily need to be applied together, nor is AIM an all-purpose replacement for OIP aerodynamic particle size distribution (APSD) measurements by full-resolution cascade impactor (CI).