1. INTRODUCTION

The purpose of this chapter is to provide guidance for biocompatibility evaluation of polymeric materials of construction and polymeric components for pharmaceutical packaging systems. Background information and principles for the application of Biological Reactivity Tests, In Vitro 〈87〉 and Biological Reactivity Tests, In Vivo 〈88〉 are provided. Additionally, principles for the toxicological evaluation of chemicals found during the application of Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 〈1663〉 or Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉 are discussed.