Introduction

This chapter focuses on the non-profile analysis, which applies to tests for dose or spray content uniformity through container life, droplet size distribution, spray pattern, and priming and re-priming. It describes past experience for in vitro bioequivalence testing, including regulatory requirements, criteria, statistical methods, and sample size requirement. Biosimilars are fundamentally different from generic chemical drugs. The chapter also describes the tiered approach recommended by the Food and Drug Administration for analytical similarity assessment. It discusses scientific factors and practical issues that are commonly encountered when performing analytical similarity assessment for identified critical quality attributes. Spray plumes characterizes at three stages: early upon formation, as the plume starts to dissipate, and at some intermediate time. The chapter also discusses study design and data collection for each of the seven in vitro tests. The chapter also presents an overview of the key concepts in this book.