Publications

Du H, Pan B, Alund AW, Yan J, Chen Y, Robison TW, Chen T. 2023. Evaluation of mutagenic susceptibility of different stages in germ cell development of Caenorhabditis elegans using whole genome sequencing. Arch Toxicol 97(8):2261-2272; doi: 10.1007/s00204-023-03526-z.

Robison TW, Heflich RH, Manjanatha MG, Elespuru R, Atrakchi A, Mei N, Ding W. 2021. Appropriate in vivo follow-up assays to an in vitro bacterial reverse mutation (Ames) test positive investigational drug candidate (active pharmaceutical ingredient), drug- related metabolite, or drug-related impurity. Mutat Res Gen Toxicol Environ Mutagen 868-869:503386; doi: 10.1016/j.mrgentox.2021.503386.

Revollo JR, McKinzie PB, Robison TW, Dobrovolsky VN. 2021. Mutational signatures in T-lymphocytes of rats treated with N-propyl-N-nitrosourea and procarbazine. Environ Mol Mutagen 62(6):350-363; doi: 10.1002/em.22448.

Robison TW. How many doses of an Ames-positive/mutagenic (DNA reactive) drug can be safely administered to healthy subjects? Genetic Toxicology Association, 2021.

Wang Y, Mittelstaedt RA, Wynne R, Chen Y, Cao X, Muskhelishvili L, Davis K, Robison TW, et al. 2021. Genetic toxicity testing using human in vitro organotypic airway cultures: Assessing DNA damage with the CometChip and mutagenesis by duplex sequencing. Environ Mol Mutagen 62(5):306-318; doi: 10.1002/em22444.

Pan B, Kaldhone PR, Alund AW, Du H, Guo X, Yan J, Chen Y,…Robison TW, et al. 2021. Mutagenicity of silver nanoparticles evaluated using whole genome sequencing in mouse lymphoma cells. Nanotoxicol 15(3):418-432; doi: 10.1080/17435390.2021.1894614.

Guo X, Seo JE, Petibone D, Tryndyak V, Lee UJ, Zhou T, Robison TW, Mei N. 2020. Performance of HepaRG and HepG2 cells in the high-throughput micronucleus assay for in vitro genotoxicity assessment. J Toxicol Environ Health A 83(21-22):702-717; doi: 10.1080/15287394.2020.1822972.

Revollo JR, Dad A, Pearce MG, Mittelstaedt RA, Casildo A, Lapidus RG, Robison TW, Dobrovolsky VN. 2020. CD59-deficient bone marrow erythroid cells from rats treated with procarbazine and propyl-nitrosourea have mutations in the Pig-a gene. Environ Mol Mutagen 61(8):797-806; doi: 10.1002/em.22402.

Seo JE, Wu Q, Bryant M, Ren L, Shi Q, Robison TW, Mei N, Manjanatha MG, Guo X. 2020. Performance of high‑throughput CometChip assay using primary human hepatocytes: A comparison of DNA damage responses with in vitro human hepatoma cell lines. Arch Toxicol 94(6):2207-2244; doi: 10.1007/s00204-020-02736-z.

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.

Revollo JR, Dad A, Pearce MG, Mittelstaedt RA, Robison TW, Dobrovolsky VN. 2019. Pig-a mutations in bone marrow erythroblasts of rats treated with 7,12-dimethyl-benz[a]anthracene. Mutat Res 848(Dec):503106; doi: 10.1016/j.mrgentox.2019.503106.

Seo JE, Tryndyak V, Wu Q, Dreval K, Pogribny I, Bryant M, Zhou T, Robison TW, et al. 2019. Quantitative comparison in vitro genotoxicity between metabolically competent HepaRG cells and HepG2 cells using the high-content Comet Chip assay. Arch Toxicol 93(5):1433-1448; doi: 10.1007/s00204-019-02406-9.

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

Revollo JR, Pearce MG, Dad A, Petibone DM, Robison TW, Roberts D, Dobrovolsky VN. 2018. Analysis of mutation in the rat Pig-a assay: I) Studies with bone marrow erythroid cells. Environ Mol Mutagen 59(8):722-732; doi: 10.1002/em.22211.

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.