Publications

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. Experience and impact of the US FDA and EMEA Voluntary Data Submissions (VXDS). Nat Rev Drug Discover 9:435-45; doi: 10.1038/nrd3116.

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

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

Elespuru RK, Agarwal R, Atrakchi A, Bigger CAH, Heflich RH, Jagannath D, Levy DD…Robison TW, et al. 2009. Current and future application of genetic toxicity assays: The role and value of in vitro mammalian assays. Toxicol Sci 109(2):172-179; doi: 10.1093/toxsci/kfp067.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2008.

Robison TW. Dealing with metabolites from an FDA perspective. Ninth Annual Land O’Lakes Bioanalytical Conference: Sponsored by the University of Wisconsin-Madison, Devil’s Head Resort, Merrimac, WI, July 2008.

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.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2007.