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An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs).
Avila AM, Bebenek I, Bonzo JA, Bourcier T, Davis Bruno KL, Carlson DB, Dubinion J, Elayan I, Harrouk W, Lee SL, Mendrick DL, Merrill JC, Peretz J, Place E, Saulnier M, Wange RL, Yao J, Zhao D, Brown PC. Avila AM, et al. Among authors: davis bruno kl. Regul Toxicol Pharmacol. 2020 Jul;114:104662. doi: 10.1016/j.yrtph.2020.104662. Epub 2020 Apr 20. Regul Toxicol Pharmacol. 2020. PMID: 32325112
The benefits, limitations and opportunities of preclinical models for neonatal drug development.
Campion S, Inselman A, Hayes B, Casiraghi C, Joseph D, Facchinetti F, Salomone F, Schmitt G, Hui J, Davis-Bruno K, Van Malderen K, Morford L, De Schaepdrijver L, Wiesner L, Kourula S, Seo S, Laffan S, Urmaliya V, Chen C. Campion S, et al. Dis Model Mech. 2022 Apr 1;15(4):dmm049065. doi: 10.1242/dmm.049065. Epub 2022 Apr 25. Dis Model Mech. 2022. PMID: 35466995 Free PMC article. Review.
Value of juvenile animal studies.
Leconte I, Bailey G, Davis-Bruno K, Hew KW, Kim J, Silva Lima B, Liminga U, Moffit J, De Schaepdrijver L, Schmitt G, Tassinari M, Thompson K, Hurtt M. Leconte I, et al. Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):292-303. doi: 10.1002/bdrb.20331. Birth Defects Res B Dev Reprod Toxicol. 2011. PMID: 22623020 Review.
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