This presentation at the 2022 Nelson Labs Virtual Symposium will focus on the typical toxicological challenges encountered in extractables and leachables (E&L) studies for small volume parenteral (SVP) applications. Attendees will be provided with detailed examples that illustrate these challenges, offering practical insights into the complexities of toxicological evaluations in this context.
The session will delve into the toxicological procedures and endpoints commonly used in E&L studies for SVPs. Participants will gain a comprehensive understanding of how to conduct these evaluations, including the methodologies employed to assess the potential risks associated with extractables and leachables.
Further, the presentation will explore possible hazard evaluation methods, explaining how to effectively identify and quantify toxicological risks. By examining these methods, attendees will learn how to implement robust hazard assessments that ensure the safety and compliance of their SVP drug products.
The conclusion will provide an overview of the current state of toxicological assessments in SVP E&L studies, summarizing key findings and offering recommendations for best practices. This comprehensive review will help professionals stay informed about the latest developments and standards in the field, enabling them to enhance their toxicological evaluation processes.
This presentation is essential for professionals involved in the toxicological assessment, development, and regulatory compliance of small volume parenteral drug products. By attending, participants will acquire valuable knowledge on addressing toxicological challenges in E&L studies, ensuring their products meet the highest standards of safety and efficacy.