Publications Co-authored by FDA on Alternative Methods
Current list of FDA co-authored articles on alternative methods
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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.
Publications
Reevaluation of the embryonic stem cell test
Gene expression profiling of cultured mouse testis fragments treated with ethinylestradiol
Evaluation of Culture Time and Media in an In Vitro Testis Organ Culture System
Evaluation of an in vitro mouse testis organ culture system for assessing male reproductive toxicity
Metabolomics‐based pathway changes in testis fragments treated with ethinylestradiol in vitro
Strategies for Rapid Risk Assessment of Color Additives Used in Medical Devices
Liver Microphysiological Systems for Predicting and Evaluating Drug Effects
Assessment of Intestinal absorption of 3-MCPD by Caco-2 cells
Predicting the mutagenic potential of chemicals in tobacco products using in silico toxicology tools.
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.
Presentations
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
FDA, ICH, and the 3Rs, September 2020
Microphysiological Systems to Assess the Functional Capacity of Cellular Therapy Products
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