THE EXTRACTABLES AND LEACHABLES SAFETY INFORMATION EXCHANGE (ELSIE): DEVELOPMENT OF AN EXTRACTABLES AND LEACHABLES DATABASE

摘要

The Extractables and Leachables Safety Information Exchange (ELSIE) is a consortium of pharmaceutical, biotech, and medical device companies that is developing a database that will hold (i) safety information on extractables and leachables from a variety of materials; and (ii) controlled extraction study information from materials used in container closure systems (CCS) and devices. The ELSIE database offers a number of valuable potential benefits including reducing duplicative safety studies, streamlining the search for safety information for extractables and leachables, and providing information that companies can use early in their development processes to streamline the extractables evaluation process, and reduce the risk of resource-draining leachables issues arising at the end of development. Ultimately this will help companies deliver high quality drug products to patients in a timely manner.