Publication Topic

leachables (11 POSTS)

2020 (1 POST)

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.

2018 (3 POSTS)

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.

2017 (3 POSTS)

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.

2016 (1 POST)

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.

2015 (2 POSTS)

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.

2008 (1 POST)

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.