Select External Publications - PETA Science Consortium International e.V.

The following list includes a selection of papers published on the use of non-animal testing approaches (not co-authored by the Science Consortium). Publications authored by the Science Consortium and its members can be found here.

Acute Systemic Toxicity Testing

Mansouri K, Karmaus AL, Fitzpatrick J, Patlewicz G, Pradeep P et. al. CATMoS: Collaborative Acute Toxicity Modeling Suite. Environ Health Perspect. 2021;129(4):47013.
Karmaus AL, Mansouri K, To KT, Blake B, Fitzpatrick J, Strickland J, Patlewicz G, Allen D, Casey W, Kleinstreuer N. Evaluation of variability across rat acute oral systemic toxicity studies. Toxicol Sci. 2022;188(1):34-47.
Hamm J, Allen D, Ceger P, Flint T, Lowit A, O’Dell L, Tao J, Kleinstreuer N. Performance of the GHS mixtures equation for predicting acute oral toxicity. Regul Toxicol Pharmacol. 2021;125:105007.
Kleinstreuer NC, Karmaus AL, Mansouri K, Allen DG, Fitzpatrick JM, Patlewicz G. Predictive models for acute oral systemic toxicity: a workshop to bridge the gap from research to regulation. Comp Toxicol. 2018;8:21-24.
Corvaro M, Gehen S, Andrews K, Chatfield R, Arasti C, Mehta J. GHS additivity formula: a true replacement method for acute systemic toxicity testing of agrochemical formulations. Regul Toxicol Pharmacol. 2016;82:99-110.
Moore NP, Andrew DJ, Bjerke DL, Creton S, Dreher D, Holmes T, Prieto P, Seidle T, Rowan TG. Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the globally harmonized system of classification and labeling of chemicals (GHS). Regul Toxicol Pharmacol. 2013;66(1):30-37.
Stoick K, Nitschke K, Sandusky C. Systemic testing by the dermal route can be precluded by new non-animal percutaneous absorption strategies. 2007;14:561-564.

Adverse Outcome Pathways

de Vries RBM, Angrish M, Browne P, Brozek J, Rooney AA, Wikoff DS, Whaley P, Edwards SW, Morgan RL, Druwe IL, Hoffmann S, Hartung T, Thayer K, Avey MT, Beverly BEJ, Falavigna M, Gibbons C, Goyak K, Kraft A, Nampo F, Qaseem A, Sears M, Singh JA, Willett C, Yost EY, Schünemann H, Tsaioun K. Applying evidence-based methods to the development and use of adverse outcome pathways. ALTEX. 2021;38(2):336-347.
Willett C. The use of adverse outcome pathways (AOPs) to support chemical safety decisions within the context of integrated approaches to testing and assessment (IATA). In: Kojima H, Seidle T, Spielmann H, eds. Alternatives to Animal Testing. Springer, Singapore; 2019:83-90.
Wittwehr C, Aladjov H, Ankley G, Byrne H, de Knecht J, Heinzle E, Klambauer G, Landesmann B, Luijten M, MacKay C, Maxwell G, Meek ME, Paini A, Perkins E, Sobanski T, Villeneuve D, Waters K, Whelan M. How adverse outcome pathways can aid the development and use of computational prediction models for regulatory toxicology. Toxicol Sci. 2017;155(2):326-336.
Kleinstreuer NC, Sullivan K, Allen D, Edwards S, Mendrick DL, Embry M, Matheson J, Rowlands JC, Munn S, Maull E, Casey W. Adverse outcome pathways: from research to regulation scientific workshop report. Regul Toxicol Pharmacol. 2016;76:39-50.
Burden N, Sewell F, Andersen ME, Boobis A, Chipman JK, Cronin MTD, Hutchinson TH, Kimber I, Whelan M. Adverse outcome pathways can drive non-animal approaches for safety assessment. J Appl Toxicol. 2015;35:971-975.
Langley G, Austin CP, Balapure AK, L.S. Birnbaum LS, Bucher JR, Fentem J, Fitzpatrick SC, Fowle JR, Kavlock RJ, Kitano H, Lidbury BA, Muotri AR, Peng SQ, Sakharov D, Seidle T, Trez T, Tonevitsky A, van de Stolpe A, Whelan M, Willett C. Lessons from toxicology: developing a 21^st-century paradigm for medical research. Environ Health Perspect. 2015;123(11):A268-A272.
Tollefsen KE, Scholz S, Cronin MT, Edwards SW, de Knecht J, Crofton K, Garcia-Reyero N, Hartung T, Worth A, Patlewicz G. Applying adverse outcome pathways (AOPs) to support integrated approaches to testing and assessment (IATA). Regul Toxicol Pharmacol. 2014;70(3):629-640.

Antibodies and Antitoxins

Gray AC, Bradbury ARM, Knappik A, Plückthun A, Borrebaeck CAK, Dübel S. Animal-derived-antibody generation faces strict reform in accordance with European Union policy on animal use. Nat Methods. 2020;17:755-756.
Bradbury ARM, Trinklein ND, Thie H, Wilkinson IC, Tandon AK, Anderson S, Bladen CL, Jones B, Aldred SF, Bestagno M, Burrone O, Maynard J, Ferrara F, Trimmer JS, Görnemann J, Glanville J, Wolf P, Frenzel A, Wong J, Koh XY, Eng HY, Lane D, Lefranc MP, Clark M, Dübel S. When monoclonal antibodies are not monospecific: hybridomas frequently express additional functional variable regions. MAbs. 2018;10(4):539-546.
Unkauf T, Miethe S, Fühner V, Schirrmann T, Frenzel A, Hust M. Generation of recombinant antibodies against toxins and viruses by phage display for diagnostics and therapy. Adv Exp Med Biol. 2016;917:55-76.
Frenzel A, Schirrmann T, Hust M. Phage display-derived human antibodies in clinical development and therapy. MAbs. 2016;8:1177-1194.
Gray A, Sidhu S, Chandrasekera P, Hendriksen C, Borrebaeck C. Animal-friendly affinity reagents: replacing the needless in the haystack. Trends Biotechnol. 2016;34(12):960-969.
Both L, White J, Mandal S, Efstratiou A. Access to diphtheria antitoxin for therapy and diagnostics. Euro Surveill. 2014;19(24):1-6.
Both L, Banyard A, van Dolleweerd C, Wright E, Ma J, Fooks A. Monoclonal antibodies for prophylactic and therapeutic use against viral infections . Vaccine. 2013;31(12):1553-1559.
Bradbury A, Sidhu S, Dübel S, McCafferty J. Beyond natural antibodies: the power of in vitro display technologies. Nat Biotechnol. 2011;29:245-254.

Biologics and Biological Assays

Poston R, Hill R, Allen C, Casey W, Gatewood D, Levis R, Mallet L, Smith D, Srinivas G, Stirling C, Allen D. Achieving scientific regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: a NICEATM and IABS workshop report. 2019;60:8-14.
De Mattia F, Hendriksen C, Buchheit KH, Chapsal JM, Halder M, Lambrigts D, Redhead K, Rommel E, Scharton-Kersten T, Sesardic T, Viviani L, Ragan I. The vaccines consistency approach project: an EPAA initiative. Pharmeur Bio Sci Notes. 2015;2015:30-56.
Simon S, Fiebig U, Liu Y, Tierney R, Dano J, Worbs S, Endermann T, Nevers MC, Volland H, Sesardic D, Dorner MB. Recommended immunological strategies to screen for botulinum neurotoxin-containing samples. Toxins (Basel). 2015;7(12):5011-5034.
Dunning FM, Piazza TM, Zeytin FN, Tucker WC. Isolation and quantification of botulinum neurotoxin from complex matrices using the BoTest matrix assays. J Vis Exp. 2014;85:e51170.
Fernández-Salas E, Wang J, Molina Y, Nelson JB, Jacky BP, Aoki KR. Botulinum neurotoxin serotype A specific cell-based potency assay to replace the mouse bioassay. PLoS One. 2012;7(11):e49516.
Sesardic T. Bioassays for evaluation of medical products derived from bacterial toxins. Curr Opin Microbiol. 2012;15(3):310-316.

Carcinogenicity

Heusinkveld H, Braakhuis H, Gommans R, Botham P, Corvaro M, van der Laan JW, Lewis D, Madia F, Manou I, Schorsch F, Wolterink G, Woutersen R, Corvi R, Mehta J, Luijten M. Towards a mechanism-based approach for the prediction of nongenotoxic carcinogenic potential of agrochemicals. Crit Rev Toxicol. 2020;50(9):725-739.
Jacobs MN, Colacci A, Corvi R, Vaccari M, Aguila MC, Corvaro M, Delrue N, Desaulniers D, Ertych N, Jacobs A, Luijten M, Madia F, Nishikawa A, Ogawa K, Ohmori K, Paparella M, Sharma AK, Vasseur P. Chemical carcinogen safety testing: OECD expert group international consensus on the development of an integrated approach for the testing and assessment of chemical non-genotoxic carcinogens. Arch Toxicol. 2020;94:2899-2923.
Luijten M, Corvi R, Mehta J, Corvaro M, Delrue N, Felter S, Haas B, Hewitt NJ, Hilton G, Holmes T, Jacobs MN, Jacobs A, Lamplmair F, Lewis D, Madia F, Manou I, Melching-Kollmuss S, Schorsch F, Schütte K, Sewell F, Strupp C, van der Laan JW, Wolf DC, Wolterink G, Woutersen R, Zvonar Z, Heusinkveld H, Braakhuis H. A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals. Regul Toxicol Pharmacol. 2020;118:104789.
Yauk CL, Harrill AH, Ellinger-Ziegelbauer H, van der Laan JW, Moggs J, Froetschl R, Sistare F, Pettit S. A cross-sector call to improve carcinogenicity risk assessment through use of genomic methodologies. Regul Toxicol Pharmaco 2020;110:104526.
Wolf DC, Cohen SM, Boobis AR, Dellarco VL, Fenner-Crisp PA, Moretto A, Pastoor TP, Schoeny RS, Seed JG, Doe JE. Chemical carcinogenicity revisited 1: a unified theory of carcinogenicity based on contemporary knowledge. Regul Toxicol Pharmacol. 2019;103:86-92.
Doe JE, Boobis AR, Dellarco V, Fenner-Crisp PA, Moretto A, Pastoor TP, Schoeny RS, Seed JG, Wolf DC. Chemical carcinogenicity revisited 2: current knowledge of carcinogenesis shows that categorization as a carcinogen or non-carcinogen is not scientifically credible. Regul Toxicol Pharmacol. 2019;103:124-129.
Cohen SM, Boobis AR, Dellarco VL, Doe JE, Fenner-Crisp PA, Moretto A, Pastoor TP, Schoeny RS, Seed JG, Wolf DC. Chemical carcinogenicity revisited 3: risk assessment of carcinogenic potential based on the current state of knowledge of carcinogenesis in humans. Regul Toxicol Pharmacol. 2019;103:100-105.
Goodman JI. Goodbye to the bioassay. Toxicol Res. 2018;7:558-564.
Corvi R, Madia F, Guyton KZ, Kasper P, Rudel R, Colacci A, Kleinjans J, Jennings P. Moving forward in carcinogenicity assessment: report of an EURL ECVAM/ESTIV workshop. Toxicol In Vitro. 2017;45:278-286.
Cohen SM. The relevance of experimental carcinogenicity studies to human safety. Curr Opin Toxicol. 2017;3:6-11.
Boobis AR, Cohen SM, Dellarco VL, Doe JE, Fenner-Crisp PA, Moretto A, Pastoor TP, Schoeny RS, Seed JG, Wolf DC. Classification schemes for carcinogenicity based on hazard-identification have become outmoded and serve neither science nor society. Regul Toxicol Pharmacol. 2016;82:158-166.
Bourcier T, McGovern T, Stavitskaya L, Kruhlak N, Jacobson-Kram D. Improving prediction of carcinogenicity to reduce, refine, and replace the use of experimental animals. J Am Assoc Lab Anim Sci. 2015;54:163-169.
Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, Storer RD, Reddy MV, Kraynak A, Trela B, Bienvenu JG, Bjurstrom S, Bosmans V, Brewster D, Colman K, Dominick M, Evans J, Hailey JR, Kinter L, Liu M, Mahrt C, Marien D, Myer J, Perry R, Potenta D, Roth A, Sherratt P, Singer T, Slim R, Soper K, Fransson-Steen R, Stoltz J, Turner O, Turnquist S, van Heerden M, Woicke J, DeGeorge JJ. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines. Toxicol Pathol. 2011;39:716-744.
Billington R, Lewis RW, Mehta JM, Dewhurst I. The mouse carcinogenicity study is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides. Crit Rev Toxicol. 2010;40:35-49.

Computer Modelling

Lizarraga LE, Suter GW, Lambert JC, Patlewic G, Zhao JC, Dean JL, Kaiser P. Advancing the science of a read-across framework for evaluation of data-poor chemicals incorporating systematic and new approach methods. Regul Toxicol Pharmacol. 2023;137:105293.
Tan YM, Chan M, Chukwudebe A, Domoradzki J, Fisher J, Hack CE, Hinderliter P, Hirasawa K, Leonard J, Lumen A, Paini A, Qian H, Ruiz P, Wambaugh J, Zhang F, Embry M. PBPK model reporting template for chemical risk assessment applications. Regul Toxicol Pharmacol. 2020;115:104691.
Patlewicz G, Lizarraga LE, Rua D, Allen DG, Daniel AB, Fitzpatrick SC, Garcia-Reyero N, Gordon J, Hakkinen P, Howard AS, Karmaus A, Matheson J, Mumtaz M, Richarz AN, Ruiz P, Scarano L, Yamada T, Kleinstreuer N. Exploring current read-across applications and needs among selected US federal agencies. Regul Toxicol Pharmacol. 2019;106:197-209.
Helman G, Shah I, Williams AJ, Edwards J, Dunne J, Patlewicz G. Generalized read-across (GenRA): a workflow implemented into the EPA CompTox Chemicals Dashboard. ALTEX. 2019;36(3):462-465.
Myatt GJ, Ahlberg E, Akahori Y, et al. In silico toxicology protocols. Regul Toxicol Pharmacol. 2018;96:1-17.
Luechtefeld T, Marsh D, Rowlands C, Hartung T. Machine learning of toxicological big data enables read-across structure activity relationships (RASAR) outperforming animal test reproducibility. Toxicol Sci. 2018;165(1):198-212.
Viceconti M, Cobelli C, Haddad T, Himes A, Kovatchev B, Palmer M. In silico assessment of biomedical products: the conundrum of rare but not so rare events in two case studies. Proc Inst Mech Eng H. 2017;231(5):455-466.
Stanton K, Kruszewski F. Quantifying the benefits of using read-across and in silico techniques to fulfill hazard data requirements for chemical categories. Regul Toxicol Pharmacol. 2016;81:250-259.
Schultz TW, Amcoff P, Berggren E, Gautier F, Klaric M, Knight DJ, Mahony C, Schwarz M, White A, Cronin MTD. A strategy for structuring and reporting a read-across prediction of toxicity. Regul Toxicol Pharmacol. 2015;72(3):586-601.
Blackburn K, Stuard SB. A framework to facilitate consistent characterization of read across uncertainty. Regul Toxicol Pharmacol. 2014;68(3):353-362.

Ecotoxicity

Fischer M, Belanger SE, Beckermans P, Bernhard MJ, Bláha L, Coman Schmid DE, Dyer SD, Haupt T, Hermems JLM, Hultman MT, Laue H, Lillicrap A, Mlnaříková M, Natsch A, Novák J, Sinnige TL, Tollefsen KE, von Niederhäusern V, Witters H, Županič A, Schirmer K. Repeatability and reproducibility of the RTgill-W1 cell line assay for predicting fish acute toxicity. Toxicol Sci. 2019;169(2):353-364.
Lillicrap A, Belanger S, Burden N, Du Pasqiuer D, Embry MR, Halder M, Lampi MA, Lee L, Norberg-King T, Rattner BA, Schirmer K, Thomas P. Alternative approaches to vertebrate ecotoxicity tests in the 21^st century: a review of developments over the last 2 decades and current status. Environ Toxicol Chem. 2016;35(11):2637-2646.
Burden N, Maynard SK, Weltje L, Wheeler JR. The utility of QSARs in predicting acute fish toxicity of pesticide metabolites: a retrospective validation approach. Regul Toxicol Pharmacol. 2016;80:241-246.
Belanger SE, Sanderson H, Embry MR, Coady K, DeZwart D, Farr BA, Gutsell S, Halder M, Sternberg R, Wilson P. It is time to develop ecological thresholds of toxicological concern to assist environmental hazard assessment. Environ Toxicol Chem. 2015;32(12):2864-2869.
Stadnicka-Michalak J, Schirmer K, Ashauer R. Toxicology across scales: cell population growth in vitro predicts reduced fish growth. Sci Adv. 2015;1(7):e1500302.
Stadnicka-Michalak J, Tanneberger K, Schirmer K, Ashauer R. Measured and modeled toxicokinetics in cultured fish cells and application to in vitro–in vivo toxicity extrapolation. PLOS One. 2014;9(3):e92303.
Belanger SE, Rawlings JM, Carr GJ. Use of fish embryo toxicity tests for the prediction of acute fish toxicity to chemicals. Environ Toxicol Chem. 2013;32(8):1768-1783.
Tanneberger K, Knöbel M, Bussert FJM, Sinnige TL, Hermens JLM, Schirmer K. Predicting fish acute toxicity using a fish gill cell line-based toxicity assay. Environ Sci Technol. 2013;47(2):1110-1119.
Baron MG, Purcell WM, Jackson SK, Owen SF, Jha AN. Towards a more representative in vitro method for fish ecotoxicology: morphological and biochemical characterisation of three-dimensional spheroidal hepatocytes. 2012;21(8):2419-2429.

Endocrine Disruption

Milcamps A, Liska R, Langezaal I, Casey W, Dent M, Odum J. Reliability of the AR-CALUX® in vitro method used to detect chemicals with (anti)androgen activity: results of an international ring trial. Toxicol Sci. 2021;184(1):170-182.
Barton-Maclaren TS, Wade M, Basu N, Bayen S, Grundy J, Marlatt V, Moore R, Parent L, Parrott J, Grigorova P, Pinsonnault-Cooper J, Langlois VS. Innovation in regulatory approaches for endocrine disrupting chemicals: the journey to risk assessment modernization in Canada. Environ Res. 2022;204(Pt C):112225.
La Merrill MA, Vandenberg LN, Smith MT, Goodson W, Browne P, Patisaul HB, Guyton KZ, Kortenkamp A, Cogliano VJ, Woodruff TJ, Rieswijk L, Sone H, Korach KS, Gore AC, Zeise L, Zoeller RT. Consensus on the key characteristics of endocrine-disrupting chemicals as a basis for hazard identification. Nat Rev Endocrinol. 2020;16(1):45-57.
Judson R, Houck K, Friedman KP, Brown J, Browne P, Johnston PA, Close DA, Mansouri K, Kleinstreuer N. Selecting a minimal set of androgen receptor assays for screening chemicals. Regulat Toxicol Pharmacol. 2020;117:104764.
Mansouri K, Kleinstreuer N, Abdelaziz AM, et al. CoMPARA: collaborative modeling project for androgen receptor activity. Environ Health Perspect. 2020;128(2):027002.
Grignard E, Håkansson H, Munn S. Regulatory needs and activities to address the retinoid system in the context of endocrine disruption: the European viewpoint. Reprod Toxicol. 2020;93:250-258.
Sharpe RM. Androgens and the masculinization programming window: human–rodent differences. Biochem Soc Trans. 2020;48(4):1725-1735.
Hanioka N, Isobe T, Tanaka-Kagawa T, Jinno H, Ohkawara S. In vitro glucuronidation of bisphenol A in liver and intestinal microsomes: interspecies differences in humans and laboratory animals. Drug Chem Toxicol. Published online 13 November. doi:10.1080/01480545.2020.1847133.
Beames T, Moreau M, Roberts LA, Mansouri K, Haider S, Smeltz M, Nicolas CI, Doheny D, Phillips MB, Yoon M, Becker RA, McMullen PD, Andersen ME, Clewell RA, Hartman JK. The role of fit-for-purpose assays within tiered testing approaches: a case study evaluating prioritized estrogen-active compounds in an in vitro human uterotrophic assay. Toxicol Appl Pharmacol. 2020;387:114774.
Moroni L, Barbaro F, Caiment F, Coleman O, Costagliola S, Di Conza G, Elviri L, Giselbrecht S, Krause C, Mota C, Nazzari M, Pennington SR, Ringwald A, Sandri M, Thomas S, Waddington J, Toni R. SCREENED: a multistage model of thyroid gland function for screening endocrine-disrupting chemicals in a biologically sex-specific manner. Int J Mol Sci. 2020;21(10):1-23.
Haggard DE, Setzer RW, Judson RS, Paul Friedman K. Development of a prioritization method for chemical-mediated effects on steroidogenesis using an integrated statistical analysis of high-throughput H295R data. Regul Toxicol Pharmacol. 2019;109:104510.
Corton JC, Kleinstreuer NC, Judson RS. Identification of potential endocrine disrupting chemicals using gene expression biomarkers. Toxicol Appl Pharmacol. 2019;380:114683.
Dent MP, Madnick SJ, Hall S, Vantangoli Policelli M, Bars C, Li H, Amin A, Carmichael PL, Martin FL, Boekelheide K. A human-derived prostate co-culture microtissue model using epithelial (RWPE-1) and stromal (WPMY-1) cell lines. Toxicol In Vitro. 2019;60:203-211.
Browne P, Kleinstreuer NC, Ceger P, Deisenroth C, Baker N, Markey K, Thomas RS, Judson RJ, Casey W. Development of a curated Hershberger database. Reprod Toxicol. 2018;81:259-271.
Judson RS, Paul Friedman K, Houck K, Mansouri K, Browne P, Kleinstreuer NC. New approach methods for testing chemicals for endocrine disruption potential. Curr Opin Toxicol. 2018;9:40-47.
Kleinstreuer NC, Browne P, Chang X, Judson R, Casey W, Ceger P, Deisenroth C, Baker N, Markey K, Thomas RS. Evaluation of androgen assay results using a curated Hershberger database. Reprod Toxicol. 2018;81:272-280.
Haggard DE, Karmaus AL, Martin MT, Judson RS, Setzer RW, Friedman KP. High-throughput H295R steroidogenesis assay: utility as an alternative and a statistical approach to characterize effects on steroidogenesis. Toxicol Sci. 2018;162(2):509-534.
Judson RS, Houck KA, Watt ED, Thomas RS. On selecting a minimal set of in vitro assays to reliably determine estrogen agonist activity. Regul Toxicol Pharmacol. 2017;91:39-49.
Kleinstreuer NC, Ceger P, Watt ED, Martin M, Houck K, Browne P, Thomas RS, Casey WM, Dix DJ, Allen D, Sakamuru S, Xia M, Huang R, Judson R. Development and validation of a computational model for androgen receptor activity. Chem Res Toxicol. 2016;30(4):946-964.

Eye Irritation/Corrosion Testing

Luechtefeld T, Maertens A, Russo DP, Rovida C, Zhu H, Hartung T. Analysis of Draize eye irritation testing and its prediction by mining publicly available 2008–2014 REACH data. ALTEX. 2016;33(2):123-134.
Lotz C, Schmid FF, Rossi A, Kurdyn S, Kampik D, De Wever B, Walles H, Groeber FK. Alternative methods for the replacement of eye irritation testing. ALTEX. 2016;33(1):55-67.
Adriaens E, Barroso J, Eskes C, Hoffmann S, McNamee P, Alépée N, Bessou-Touya S, De Smedt A, De Wever B, Pfannenbecker U, Tailhardat M, Zuang V. Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods. Arch Toxicol. 2014;88(3):701-723.

Foetal Bovine Serum

Rafnsdóttir ÓB, Kiuru A, Tebäck M, Friberg N, Revstedt P, Zhu J, Thomasson S, Czopek A, Malakpour-Permlid A, Weber T, Oredsson S. A new animal product free defined medium for 2D and 3D culturing of normal and cancer cells to study cell proliferation and migration as well as dose response to chemical treatment. Toxicol Rep. 2023;12(10):509-520.
Chary A. Culturing human lung adenocarcinoma cells in a serum-free environment. Methods Mol Biol. 2023;2645:165-172.
Perez-Diaz N, Hoffman E, Clements J, Cruickshank R, Doherty A, Ebner D, Elloway J, Fu J, Kelsall J, Millar V, Saib O, Scott A, Woods I, Hutter V. Longitudinal characterization of TK6 cells sequentially adapted to animal product-free, chemically defined culture medium: considerations for genotoxicity studies. Front Toxicol. 2023;5:1177586.
Weber T, Wiest J, Oredsson S, Bieback K. Case studies exemplifying the transition to animal component-free cell culture. ATLA. 2022;50(5):330-338.
Kim JY, Rhim WK, Seo HJ, Lee JY, Park CG, Han DK. Comparative analysis of MSC-derived exosomes depending on cell culture media for regenerative bioactivity. Tissue Eng Regen Med. 2021;18(3):355–367.
Cimino M, Gonçalves RM, Barrias CC, Martins MCL. Xeno-free strategies for safe human mesenchymal stem/stromal cell expansion: supplements and coatings. Stem Cells Int. 2017;2017:6597815.

Genotoxicity

Buick JK, Williams A, Meier MJ, Swartz CD, Recio L, Gagné R, Ferguson SS, Engelward BP, Yauk CL. A modern genotoxicity testing paradigm: integration of the high-throughput CometChip® and the TGx-DDI Transcriptomic Biomarker in human HepaRGTM cell cultures. Front Pub Health. 2021;9:1-19.
Pfuhler S, Downs TR, Hewitt NJ, Hoffmann S, Mun GC, Ouedraogo G, Roy S, Curren RD, Aardema MJ. Validation of the 3D reconstructed human skin micronucleus (RSMN) assay: an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays. Mutagenesis. 2021;36(1):1-17.
Pfuhler, S, Pirow, R, Downs TR, Haase A, Hewitt N, Luch A, Merkel M, Petrick C, Said A, Schäfer-Korting M, Reisinger K. Validation of the 3D reconstructed human skin Comet assay, an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays. Mutagenesis. 2021;36(1):19-35.
Llewellyn S, Conway G E, Zanon I, Jørgensen AK, Shah U, Seleci DA, Keller JG, Kim JW, Wohlleben W, Jensen KA, Costa A, Jenkins GJS, Clift MJD, Doak SH. Understanding the impact of more realistic low-dose, prolonged engineered nanomaterial exposure on genotoxicity using 3D models of the human liver. J Nanobiotech. 2021;19(1):193-217.
Brandsma I, Moelijker N, Derr R, Hendriks G. Aneugen versus clastogen evaluation and oxidative stress-related mode-of-action assessment of genotoxic compounds using the ToxTracker reporter assay. Toxicol Sci. 2020;177(1):202-213.
Conway GE, Shah UK, Llewellyn S, Cervena T, Evans SJ, Ali ASA, Jenkins GJ, Clift MJD, Doak SH. Adaptation of the in vitro micronucleus assay for genotoxicity testing using 3D liver models supporting longer-term exposure durations. Mutagenesis. 2020;35(4):319-330.
Madia F, Kirkland D, Morita T, White P, Asturiol D, Corvi R. EURL ECVAM genotoxicity and carcinogenicity database of substances eliciting negative results in the Ames Test: construction of the database. Mutat Res Genet Toxicol Environ Mutagen. 2020;854-855:503199.
Pfuhler S, van Benthem J, Curren R, Doak SH, Dusinska M, Hayashi M, Heflich RH, Kidd D, Kirkland D, Luan Y, Ouedraogo G, Reisinger K, Sofuni T, van Acker F, Yang Y, Corvi R. Use of in vitro 3D tissue models in genotoxicity testing: strategic fit, validation status and way forward. Report of the working group from the 7th International Workshop on Genotoxicity Testing (IWGT). Mutat Res Gen Tox En. 2020;850-851:503135-503145.
Sasaki JC, Allemang A, Bryce SM, Custer L ,Dearfield KL, Dietz Y, Elhajouji A, Escobar PA, Fornace Jr AJ, Froetschl R, Galloway S, Hemmann U, Hendriks G, Li H, Luijten M, Ouedraogo G, Peel L, Pfuhler S, Roberts DJ, Thybaud V, van Benthem J, Yauk CL, Schuler M. Application of the adverse outcome pathway framework to genotoxic modes of action. Environ Mol Mutagen. 2020;61(1):114-134.
Li H-H, Yauk CL, Chen R, Hyduke DR, Williams A, Frötschl R, Ellinger-Ziegelbauer H, Pettit S, Aubrecht J, Fornace Jr AJ. TGx-DDI, a transcriptomic biomarker for genotoxicity hazard assessment of pharmaceuticals and environmental chemicals. Front Big Data. 2019;2:36.
Hendriks G, Derr RS, Misovic B, Morolli B, Calléja FMGR, Vrieling H. The extended ToxTracker assay discriminates between induction of DNA damage, oxidative stress, and protein misfolding. Toxicol Sci. 2016;150(1):190-203.
Barber C, Amberg A, Custer L, Dobo KL, Glowienke S, Gompel JV, Gutsell S, Harvey J, Honma M, Kenyon MO, Kruhlak N, Muster W, Stavitskaya L, Teasdale A, Vessey J, Wichard J. Establishing best practise in the application of expert review of mutagenicity under ICH M7. Regul Toxicol Pharmacol. 2015;73(1):367-377.

In Vitro to In Vivo Extrapolation

Bell S, Abedini J, Ceger P, Chang X, Cook B, Karmaus AL, Lea I, Mansouri K, Phillips J, McAfee E, Rai R, Rooney J, Sprankle C, Tandon A, Allen D, Casey W, Kleinstreuer N. An integrated chemical environment with tools for chemical safety testing. Toxicol In Vitro. 2020;67:104916.
Bell S, Chang X, Wambaugh J, Allen D, Bartels M, Brouwer K, Casey W, Choks N, Perguson S, Fraczkiewicz G, Jarabek A, Ke A, Lumen A, Lynn S, Paini A, Price P, Ring C, Simon T, Sipes N. In vitro to in vivo extrapolation for high throughput prioritization and decision making. Toxicol In Vitro. 2018;47:213-227.

Inhalation Toxicity Testing

Paudel I, Barutcu AR, Samuel R, Moreau M, Slattery SD, Scaglione J, Recio L. Increasing confidence in new approach methodologies for inhalation risk assessment with multiple end point assays using 5-day repeated exposure to 1,3-dichloropropene. Toxicology. 2023;499:153642.
Ramanarayanan T, Szarka A, Flack S, Hinderliter P, Corley R, Charlton A, Pyles S, Wolf D. Application of a new approach method (NAM) for inhalation risk assessment. Regul Toxicol Pharmacol. 2022;133:105216.
Moreau M, Fisher J, Andersen ME, Barnwell A, Corzine S, Ranade A, McMullen PD, Slattery SD. NAM-based prediction of point-of-contact toxicity in the lung: A case example with 1,3-dichloropropene. Toxicology. 2022;481(July):153340.
Da Silva E, Vogel U, Hougaard KS, Pérez-Gil J, Zuo YY, Sørli JB. An adverse outcome pathway for lung surfactant function inhibition leading to decreased lung function. Curr Res Toxicol. 2021;2:225-236.
Hargrove MM, Dobrzansk BP, Li L, Constant S, Wallace J, Hinderliter P, Wolf DC, Charlton A. Use of the MucilAir airway assay, a new approach methodology, for evaluating the safety and inhalation risk of agrochemicals. Appl Vitr Toxicol. 2021;7(2):50-60.
Bluhmki T, Bitzer S, Gindele JA, Schruf E, Kiechle T, Webster M, Schymeinsky J, Ries R, Gantner F, Bischoff D, Garnett J, Heilker R. Development of a miniaturized 96-Transwell air–liquid interface human small airway epithelial model. Sci Rep. 2020;10:13022.
Mistry A, Bowen LE, Dzierlenga MW, Hartman JK, Slattery SD. Development of an in vitro approach to point-of-contact inhalation toxicity testing of volatile compounds, using organotypic culture and air-liquid interface exposure. Toxicol In Vitro. 2020;69:104968.
Marescotti D, Serchi T, Luettich K, Xiang Y, Moschini E, Talikka M, Martin F, Baumer K, Dulize R, Peric D, Bornand D, Guedj E, Sewer A, Cambier S, Contal S, Chary A, Gutleb AC, Frentzel S, Ivanov NV, Peitsch MC, Hoeng J. How complex should an in vitro model be? Evaluation of complex 3D alveolar model with transcriptomic data and computational biological network models. ALTEX. 2019;36(3):388-402.
Felder M, Trueeb B, Stucki AO, Borcard S, Stucki JD, Schnyder B, Geiser T, Guenat OT. Impaired wound healing of alveolar lung epithelial cells in a breathing lung-on-a-chip. Front Bioeng Biotechnol. 2019;7:3.
Luettich K, Talikka M, Lowe F, Haswell L, Park J, Gaca M, Hoeng J. The adverse outcome pathway for oxidative stress-mediated EGFR activation leading to decreased lung function. Appl In Vitro Toxicol. 2017;3(1):99-109.
Behrsing HP, Huang S, Constant S. The use of human 3D reconstructed airway cultures for tobacco product evaluation: precision low-volume exposures at the apical site. Appl In Vitro Toxicol. 2017;3(1):56-67.
Mottas I, Milosevic A, Petri-Fink A, Rothen-Rutishauser B, Bourquin C. A rapid screening method to evaluate the impact of nanoparticles on macrophages. Nanoscale. 2017;9(7):2492-2504.
Weisensee D, Poth A, Roemer E, Conroy LL, Schlage WK. Cigarette smoke–induced morphological transformation of Bhas 42 cells in vitro. Altern Lab Anim. 2013;41(2):181-189.
Mathis C, Poussin C, Weisensee D, Gebel S, Hengstermann A, Sewer A, Belcastro V, Xiang Y, Ansari S, Wagner S, Hoeng J, Peitsch MC. Human bronchial epithelial cells exposed in vitro to cigarette smoke at the air-liquid interface resemble bronchial epithelium from human smokers. Am J Physiol Lung Cell Mol Physiol. 2013;304(7):L489-L503.

Organs-on-Chips

Bahinski A, Horland R, Huh D, Mummery C, Tagle DA, MacGill T. The promise and potential of “organs-on-chips” as preclinical models. Appl In Vitro Toxicol. 2015;1(4):235-242.
Kim HJ, Ingber DE. Gut-on-a-chip microenvironment induces human intestinal cells to undergo villus differentiation. Integr Biol (Camb). 2013;5(9):1130-1140.
Jang KJ, Mehr AP, Hamilton GA, McPartlin LA, Chung S, Suh KY, Ingber DE. Human kidney proximal tubule-on-a-chip for drug transport and nephrotoxicity assessment. Integr Biol (Camb). 2013;5(9):1119-1129.
Huh D, Leslie DC, Matthews BD, Fraser JP, Jurek S, Hamilton GA, Thorneloe KS, McAlexander MA, Ingber DE. A human disease model of drug toxicity–induced pulmonary edema in a lung-on-a-chip microdevice. Sci Transl Med. 2012;4(159):159ra147.

Pyrogenicity Testing

Borton LK, Coleman KP. Material-mediated pyrogens in medical devices: applicability of the in vitro monocyte activation test. ALTEX. 2018;35(4):453-463.
Fennrich S, Hennig U, Toliashvili L, Schlensak C, Wendel H, Stoppelkamp S. More than 70 years of pyrogen detection: current state and future perspectives. Altern Lab Anim. 2016;44(3):239-253.
da Silva C, Presgrave O, Hartung T, de Moraes A, Delgado I. Applicability of the monocyte activation test (MAT) for hyperimmune sera in the routine of the quality control laboratory: comparison with the rabbit pyrogen test (RPT). Toxicol In Vitro. 2016;32:70-75.
Stang K, Fennrich S, Krajewski S, Stoppelkamp S, Burgener I, Wendel H, Post, M. Highly sensitive pyrogen detection on medical devices by the monocyte activation test. J Mater Sci Mater Med. 2014;25(4):1065-1075.
Hasiwa N, Daneshian M, Bruegger P, Fennrich S, Hochadel A, Hoffmann S, Rivera-Mariani FE, Rockel C, Schindler S, Spreitzer I, Stoppelkamp S, Vysyaraju K, Hartung T. Evidence for the detection of non-endotoxin pyrogens by the whole blood monocyte activation test. ALTEX. 2013;30(2):169-208.
Hennig U. Implementing the in vitro pyrogen test: one more step toward replacing animal experimentation. Altern Lab Anim. 2013;41:58-60.
Daneshian M, von Aulock S, Hartung T. Assessment of pyrogenic contaminations with validated human whole-blood assay. Nat Protoc. 2009;4(12):1709-1721.

Regulatory Assessment

Magurany KA, Chang X, Clewell R, Coecke S, Haugabrooks E, Marty S. A pragmatic framework for the application of new approach methodologies in One Health toxicological risk assessment. Toxicol Sci. 2023;192(2):155-177.
Bhuller Y, Ramsingh D, Beal M, Kulkarni S, Gagne M, Barton-Maclaren, TS. Canadian regulatory perspective on next generation risk assessments for pest control products and industrial chemicals. Front Toxicol. 2021;3:748406.
Harrill JA, Viant MR, Yauk CL, Sachana M, Gant TW, Auerbach SS, Beger RD, Bouhifd M, O’Brien J, Burgoon L, Caiment F, Carpi D, Chen T, Chorley BN, Colbourne J, Corvi R, Debrauwer L, O’Donovan C, Ebbels TMD, Ekman DR, Faulhammer F, Gribaldo L, Hilton GM, Jones SP, Kende A, Lawson TN, Leite SB, Leonards PEG, Luijten M, Martin A, Moussa L, Rudaz S, Schmitz O, Sobanski T, Strauss V, Vaccari M, Vijay V, Weber RJM, Williams AJ, Williams A, Thomas RS, Whelan M. Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology. Regul Toxicol Pharmacol. 2021;125:105020.
Wolf DC, Aggarwal M, Battalora M, Blacker A, Catalano SI, Cazarin K, Lautenschalaeger D, Pais MC, Rodriguez M, Rupprecht K, Serex TL, Mehta J. Implementing a globally harmonized risk assessment-based approach for regulatory decision-making of crop protection products. Pest Manag Sci. 2020;76(10):3311-3315.
Craig E, Lowe K, Akerman G, Dawson J, May B, Reaves E, Lowit A. Reducing the need for animal testing while increasing efficiency in a pesticide regulatory setting: lessons from the EPA Office of Pesticide Programs’ Hazard and Science Policy Council. Regul Toxicol Pharmacol. 2019;108:104481.

Reproductive Toxicity Testing

Wu S, Fisher J, Naciff J, Laufersweiler M, Lester C, Daston G, Blackburn K. Framework for identifying chemicals with structural features associated with the potential to act as developmental or reproductive toxicants. Chem Res Toxicol. 2013;26(12):1840-1861.
Fegert I, Billington R, Botham P, Carney E, FitzGerald RE, Hanley T, Lewis R, Marty MS, Schneider S, Sheets LP, Stahl B, van Ravenzwaay B. Feasibility of the extended one-generation reproductive toxicity study (OECD 443). Reprod Toxicol. 2012;34(3):331-339.

Respiratory Sensitisation

Sullivan KM, Enoch SJ, Ezendam J, Sewald K, Roggen EL, Cochrane S. An adverse outcome pathway for sensitization of the respiratory tract by low-molecular-weight chemicals: building evidence to support the utility of in vitro and in silico methods in a regulatory context. Appl In Vitro Toxicol. 2017;3(3):213-226.

Shellfish Toxicity Testing

Turner AD, Dhanji-Rapkova M, Fong SYT, Hungerford J, McNabb PS, Boundy MJ, Harwood DT. Ultrahigh-performance hydrophilic interaction liquid chromatography with tandem mass spectrometry method for the determination of paralytic shellfish toxins and tetrodotoxin in mussels, oysters, clams, cockles, and scallops: collaborative study. J AOAC Int. 2020;103(2):533-562.
Ruberu SR, Langlois GW, Masuda M, Kittredge C, Perera SK, Kudela RM. Receptor binding assay for the detection of paralytic shellfish poisoning toxins: comparison to the mouse bioassay and applicability under regulatory use. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2018;35(1):144-158.
Rourke WA, Murphy CJ. Animal-free paralytic shellfish toxin testing – the Canadian perspective to improved health protection. J AOAC Int. 2014;97(2):334-338.
Stewart I, McLeod C. The laboratory mouse in routine food safety testing for marine algal biotoxins and harmful algal bloom toxin research: past, present and future. J AOAC Int. 2014;97(2):356-372.
Daneshian M, Botana LM, Dechraoui Bottein MY, Buckland G, Campàs M, Dennison N, Dickey RW, Diogène J, Fessard V, Hartung T, Humpage A, Leist M, Molgó J, Quilliam MA, Rovida C, Suarez-Isla BA, Tubaro A, Wagner K, Zoller O, Dietrich D. A roadmap for hazard monitoring and risk assessment of marine biotoxins on the basis of chemical and biological test systems. ALTEX. 2013;30(4):487-545.

Skin Absorption

Allen DG, Rooney J, Kleinstreuer N, Lowit A, Perron M. Retrospective analysis of dermal absorption triple pack data. ALTEX. 2021;38(3):463-476.
Sullivan KM, Aggarwal M, Akins JM, Fabian E, Heylings JR, Raabe H, Shah PV, Wiemann C, Peffer R. Dermal absorption for pesticide health risk assessment: harmonization of study design and data reporting for North American regulatory submissions. Regul Toxicol Pharmacol. 2017;90:197-205.

Skin Irritation/Corrosion Testing

Raabe HA, Costin GE, Allen DG, Lowit A, Corvaro M, O’Dell L, Breeden-Alemi J, Page K, Perron M, Flint Silva T, Westerink W, Baker E, Sullivan K. Human relevance of in vivo and in vitro skin irritation tests for hazard classification of pesticides. Cutan Ocul Toxicol. 2024. https://doi.org/10.1080/15569527.2024.2387596.
Rooney JP, Choksi NY, Ceger P, Daniel AB, Truax J, Allen D, Kleinstreuer N. Analysis of variability in the rabbit skin irritation assay. Regul Toxicol Pharmacol. 2021;122:104920.
De Jong WH, Carraway JW, Liu C, Fan C, Liu J, Turley AP, Rollins TS, Coleman KP. The suitability of reconstructed human epidermis models for medical device irritation assessment: a comparison of in vitro and in vivo testing results. Toxicol In Vitro. 2020;69:104995.
De Jong WH, Hoffmann S, Lee M, Kandárová H, Pellevoisin C, Haishima Y, Rollins B, Zdawzcyk A, Willoughby J, Bachelor M. Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts. Toxicol In Vitro. 2018;50:439-449.
Li N, Liu Y, Qiu J, Zhong L, Alepee N, Cotovio J, Cai Z. In vitro skin irritation assessment becomes a reality in China using a reconstructed human epidermis test method. Toxicol In Vitro. 2017;41:159-167.
Kolle SN, Sullivan KM, Mehling A, van Ravenzwaay B, Landsiedel R. Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: substantiating test strategies with data from routine studies. Regul Toxicol Pharmacol. 2013;65(3):366-378.
Casas JW, Lewerenz GM, Rankin EA, Willoughby Sr. JA, Blakeman LC, McKim Jr. JM, Coleman KP. In vitro human skin irritation test for evaluation of medical device extracts. Toxicol In Vitro. 2013;27(8):2175-2183.

Skin Sensitisation Testing

Natsch A, Kleinstreuer N, Asturiol D. Reduced specificity for the local lymph node assay for lipophilic chemicals: implications for the validation of new approach methods for skin sensitization. Regul Toxicol Pharmacol. 2023;105333.
Strickland J, Allen DG, Germolec D, Kleinstreuer N, Johnson VJ, Gulledge T, Truax J, Lowit A, Dole T, McMahon T, Panger M, Facey J, Savage S. Application of Defined Approaches to assess skin sensitization potency of isothiazolinone compounds. App In Vit Toxicol. 2022;8(4):117-128.
Strickland J, Truax J, Corvaro M, Settivari R, Henriquez J, McFadden J, Gulledge T, Johnson V, Gehen S, Germolec D, Allen DG, Kleinstreuer N. Application of defined approaches for skin sensitization to agrochemical products. Front Toxicol. 2022;4:852856.
Natsch A, Haupt T, Wareing B, Landsiedel R, Kolle SN. Predictivity of the kinetic direct peptide reactivity assay (kDPRA) for sensitizer potency assessment and subclassification. ALTEX. 2020;37(4):652-664.
Basketter D, Azam P, Casati S, Corvaro M, Ezendam J, Griem P, Hubesch B, Irizar A, Kern P, Manou I, Mehling A, Rossi LH. Applying non-animal strategies for assessing skin sensitisation report from an EPAA/cefic-LRI/IFRA Europe cross sector workshop, ECHA Helsinki, February 7^th and 8^th 2019. Regul Toxicol Pharmacol. 2019;109:104477.
Hoffmann S, Kleinstreuer N, Alépée N, Allen D, Api AM, Ashikaga T, Clouet E, Cluzel M, Desprez B, Gellatly N, Goebel C, Kern PS, Klaric M, Kühnl J, Lalko JF, Martinozzi-Teissier S, Mewes K, Miyazawa M, Parakhia R, van Vliet E, Zang Q, Petersohn D. Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database. Crit Rev Toxicol. 2018;48(5):344-358.
Kleinstreuer NC, Hoffmann S, Alépée N, Allen D, Ashikaga T, Casey W, Clouet E, Cluzel M, Desprez B, Gellatly N, Göbel C, Kern PS, Klaric M, Kühnl J, Martinozzi-Teissier S, Mewes K, Miyazawa M, Strickland J, van Vliet E, Zang Q, Petersohn D. Non-animal methods to predict skin sensitization (II): an assessment of defined approaches. Crit Rev Toxicol. 2018;48(5):359-374.
Strickland J, Zang Q, Paris M, Lehmann DM, Allen D, Choksi N, Matheson J, Jacobs A, Casey W, Kleinstreuer N. Multivariate models for prediction of human skin sensitization hazard. J Appl Toxicol. 2017;37(3):347-360.
Zang Q, Paris M, Lehmann DM, Bell S, Kleinstreuer N, Allen D, Matheson J, Jacobs A, Casey W, Strickland J. Prediction of skin sensitization potency using machine learning approaches. J Appl Toxicol. 2017;37(7):792-805.
Jaworska JS, Natsch A, Ryan C, Strickland J, Ashikaga T, Miyazawa M. Bayesian integrated testing strategy (ITS) for skin sensitization potency assessment: a decision support system for quantitative weight of evidence and adaptive testing strategy. Arch Toxicol. 2015;89(12):2355-2383.
Coleman KP, McNamara LR, Grailer TP, Willoughby JA, Keller DJ, Patel P, Thomas S, Dilworth C. Evaluation of an in vitro human dermal sensitization test for use with medical device extracts. Applied In Vitro Toxicol. 2015;1(2):118-130.
Jaworska J, Dancik Y, Kern P, Gerberick F, Natsch A. Bayesian integrated testing strategy to assess skin sensitization potency: from theory to practice. J Appl Toxicol. 2013;33(11):1353-1364.
Bauch C, Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R. Putting the parts together: combining in vitro methods to test for skin sensitizing potentials. Regul Toxicol Pharmacol. 2012;63(3):489-504.
Troutman JA, Foertsch LM, Kern PS, Dai HJ, Quijano M. The incorporation of lysine into the peroxidase peptide reactivity assay for skin sensitization assessments. Toxicol Sci. 2011;122(2):422-436.

Thrombogenicity

Wolf MF, Girdhar G, Anderson AA, Ubl SR, Thinamany S, Jeffers HN, DeRusha CE, Rodriguez-Fernandez J, Hoffmann S, Strief, CA. In vitro methodology for medical device material thrombogenicity assessments: a use condition and bioanalytical proof-of-concept approach. J Biomed Mater Res. 2021;109(3);358-376.
Wolf MF, Anderson JM. Practical approach to blood compatibility assessments: general considerations and standards. In: Boutrand J-P, ed. Biocompatibility and Performance of Medical Devices. 2^nd Woodhead Publishing; 2020:167-205.
Girdhar G, Ubl S, Jahanbekam R, Thinamany S, Belu A, Wainwright J, Wolf MF. Thrombogenicity assessment of Pipeline, Pipeline Shield, Derivo and P64 flow diverters in an in vitro pulsatile flow human blood loop model. eNeurologicalSci. 2019;14:77-84.
Girdhar G, Andersen A, Pangerl E, Jahanbekam R, Ubl S , Nguyen K, Wainwright J, Wolf Thrombogenicity assessment of Pipeline Flex, Pipeline Shield, and FRED flow diverters in an in vitro human blood physiological flow loop model. J Biomed Mater Res A. 2018;106(12):3195-3202.

Validation

Pham LL, Watford S, Pradeep P, Martin MT, Thomas R, Judson R, Setzer RW, Friedman KP. Variability in in vivo studies: defining the upper limit of performance for predictions of systemic effect levels. Comput Toxicol. 2020;15:100126.