M. Bothe

Evaluating local neurotoxicity potential of extractables and leachables: Comparison of in vivo and in vitro data and need for new approach methods.

Animal testing remains the main regulatory approach in preclinical drug development, and may be used to analyze safety concerns (qualification) of potential leachables from container closure systems for high risk routes of administration such as intrathecal or epidural products. These studies are technically challengin...