FDA scientists from across the agency have contributed to a growing number of peer-reviewed journals on topics related to advancing alternative methods. The list below is current and updated regularly.
Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes
Tronolone, J. J., Lam, J., Agrawal, A. & Sung, K. Pumpless, modular, microphysiological systems enabling tunable perfusion for long-term cultivation of endothelialized lumens. Biomed Microdevices 23, 25 (2021).
Knudsen TB, Fitzpatrick SC, De Abrew, et al. Predictive Toxicology for Healthy Children. Toxicol Sci.
Richard AM, Huang R, Waidyanatha S, Shinn P, et al. The Tox21 compound library: collaborative chemistry advancing toxicology. Chem Res Toxicol 34(2):189-216.
Choksi N, Lebrun S, Nguyen M, et al. Validation of the OptiSafe™ eye irritation test. Cutan Ocul Toxicol 39(3):180-192.
Kleinstreuer NC, Tong W, et al. Tetko, I V. Computational toxicology. Chem Res Toxicol 33(3):687-688.
Mansouri K, Kleinstreuer N, Abdelaziz AM, et al. CoMPARA: Collaborative Modeling Project for Androgen Receptor Activity. Environ Health Perspect 128(2):027002
Parish ST, Aschner M, Casey W, Corvaro M, Embry MR, Fitzpatrick S, et al. Reg Toxicol Pharmacol 112:104592.
Prior H, Baldrick P, Beken S, Booler S, Bower N, Brooker P, Brown P, et al. Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation. Reg Toxicol Pharmacol 113:104624.
Rovida C, Barton-Maclaren T, Benfenati E, Caloni F, Chandrasekera C, Chesne C, Cronin MTD, De Knecht J, Dietrich DR, Escher SE, Fitzpatrick S, et al. Internationalization of read-across as a validation new approach method (NAM) for regulatory toxicology. ALTEX 37(4):579-606.
Choksi NY, Truax J, Layton A, Matheson J, Mattie D, Varney T, Tao J, Yozzo K, McDougal AJ, Merrill J, Lowther D, et al. United States regulatory requirements for skin and eye irritation testing. Cutan Ocular Toxicol 38(2):141-155.
Patlewicz G, Lizarraga L, Rua D, Allen DG, Daniel A, Fitzpatrick SC, et al. Exploring current read-across applications and needs among selected U.S. federal agencies. Regul Toxicol Pharmacol 106:197-209.
Poston R, Hill R, Allen C, Casey W, Gatewood D, Levis R, et al. Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: A NICEATM and IABS workshop report. Biologicals 60:8-14.
Strickland J, Daniel AB, Allen D, Aguila C, Ahir S, Bancos S, Craig E, Germolec D, Ghosh C, Hudson NL, Jacobs A, et al. Skin sensitization testing needs and data uses by U.S. regulatory and research agencies. Arch Toxicol 92(2):273-291.
Wei Z, Sakamuru S, Zhang L et al. Identification and profiling of environmental chemicals that inhibit the TGFβ/SMAD signaling pathway. Chem Res Toxicol 32(12):2433-2444.
Advancing Alternatives at FDA, given by Donna L. Mendrick, Ph.D.
at the IUTOX panel discussion at the Society of Toxicology Annual Meeting on March 16, 2021
Predicting the Effects of Candidate Drugs: The Future, given by Janet Woodcock, M.D.
Nov. 18, 2020 at the American College of Toxicology Annual Meeting