Publications

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.

Barat S, Robison TW. Information and report formats to facilitate safety qualifications. USP/PQRI/FDA Annual Meeting, 2014/2013.

Robison TW, Barat SA. Information and report formats to facilitate safety qualifications suitability and compatibility for packaging and delivery systems. Workshop Co- sponsored by USP and PQRI, USP Meetings Center, Rockville, Maryland, April 28, 2014.

Robison TW. Regulatory review of XELJANZ® (Tofacitinib) from the nonclinical perspective. American College of Toxicology Annual Meeting, 2013.

Robison TW. 2011. Dealing with positive in vitro mammalian cell genotoxicity assays. Inter Drug Discovery 6(5):40-43.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, October 2011.

Dobrovolsky VN, Elespuru RK, Bigger CA, Robison TW, Heflich RH. 2011. Monitoring humans for somatic mutation in the endogenous PIG-a gene using red blood cells. Environ Mol Mutagen 52(9):784-94; doi: 10.1002/em.20667.

Robison TW. Genotoxic impurity guidance – Current experiences, FDA perspective. USP Annual Meeting, New Orleans, LA, December 2010.

Robison TW. Dealing with positive in vitro mammalian cell genotoxicity assays. IQPC Genotoxicity and Carcinogenicity Testing 2010 Conference, London, UK, October 2010.

Robison TW. Dealing with genotoxic impurities from a regulatory perspective. IQPC Genotoxicity and Carcinogenicity Testing 2010 Conference, London, UK, October 2010.

Robison TW. Assessing genotoxic impurities. DIA Meeting (Early drug development: Navigating the treacherous rapids). Bethesda, MD, October 2010

Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Catalano J, Carl K, Charlab C,…, Robison TW, et al. 2010. Voluntary exploratory data submissions to the US FDA and the EMA: Experience and impact. Nat Rev Drug Discover 9(6):435-45; doi: 10.1038/nrd3116. PMID: 20514070.

Robison TW, Jacobs A. 2009. Metabolites in safety testing. Bioanalysis 1(7):1193-1200; doi: 10.4155/bio.09.98. PMID: 21083045.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2009.