Publication Topic

Muller K, Unice K, Panko J, Ferrari BJD, Breider F, Wagner S. 2025. Risk assessment of tire wear in the environment—A literature review. Environ Sci Process Impacts 27(8):2212-2232; doi: 10.1039/d5em00088b. PMID: 40569214.

Mihalchik A, Wood M. Considerations for standardization and derivation of pediatric and neonatal tolerable exposure limits for extractable and leachable compounds from medical devices. Poster presented at Society of Toxicology 61st Annual Meeting, San Diego, CA, March 2022.

Robison TW. Regulatory evaluation of leachables that are potential sensitizers. Symposium: Harnessing Current Knowledge on Sensitization Thresholds and Applying It to Extractable and Leachable Impurities in Drug-Device Combination Products, American College of Toxicology Annual Meeting, 2020.

Robison TW. Extractables and leachables: Outline of current regulatory framework – Challenges and uncertainties. Webinar presentation to Turkish Regulatory Authority and Pharmaceutical Association, December 2018.

Robison TW. Use of thresholds for the safety qualification of leachables in parenteral drug products from a regulatory perspective. Smithers Rapra Extractables and Leachables USA Annual Meeting, 2018.

Robison TW. Extractables and leachables: Application of thresholds and expectations: Regulatory perspectives. USP/PQRI/FDA Annual Meeting, 2018.

Robison TW. Dealing with extractables & leachables from a regulatory perspective: 1. Design of extractables & leachables studies; and 2. Safety assessment of leachables. Smithers Rapra Extractables and Leachables USA Annual Meeting, 2017.

Robison TW. Dealing with extractables & leachables from a regulatory perspective: 1. Design of extractables & leachables studies; and 2. Safety assessment of leachables. USP/PQRI/FDA Annual Meeting, 2017.

Robison TW. Dealing with extractables & leachables from a regulatory perspective: 1. Design of extractables & leachables studies; and 2. Safety assessment of leachables. American Association for Pharmaceutical Sciences, 2017.

Robison TW. Extractables & leachables: 1. Design of extractables & leachables studies; and 2. Safety assessment of leachables. Smithers Rapra Extractables and Leachables USA Annual Meeting, 2016.

Robison TW. Safety assessment of extractables and leachables from a regulatory perspective. Smithers Rapra Extractables and Leachables USA Annual Meeting, 2015.

Robison TW. Safety assessment of extractables and leachables from a regulatory perspective. American College of Toxicology Annual Meeting, 2015.

Robison TW. Case examples of qualification of extractables and leachables in therapeutic biologic products: A toxicological perspective. WCBP CMC Strategy Forum–Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development (Sponsored by CASSS and the United States Food and Drug Administration), Washington, DC, January 2008.