The ELSIE Initiative: Me of Enables/Leachables Databases in Safety Assessments

摘要

Pharmaceutical products produce a desirable therapeutic outcome when they are administered to a subject to address an issue related to health. In order to produce the desired therapeutic outcome, pharmaceutical products must be manufactured, stored, and administered (delivered). Systems that accomplish these objectives, such as manufacturing suites, packaging, and devices, have very specific and exacting performance requirements. Such performance requirements are met as a result of the system's design and materials of construction. These performance requirements are often most effectively fulfilled by plastic materials; thus it is not surprising that plastic materials are widely used in the pharmaceutical industry.