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  1. About Science & Research at FDA

Publications Co-authored by FDA on Alternative Methods

Current list of FDA co-authored articles on alternative methods

Publications on alternative methods co-authored by FDA scientists
Publications on alternative methods co-authored by FDA scientists

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. 


Development, Testing, Parameterisation and Calibration of a Human PBPK Model for the Plasticiser, Di-(2-propylheptyl) Phthalate (DPHP) Using in Silico, in vitro and Human Biomonitoring Data, McNally K, Sams C, Hogg A, Lumen A, Loizou G. Front Pharmacol. 12:692442 10.3389/fphar.2021.692442

Human microphysiological systems for drug development, Adrian Roth and MPS-WS Berlin 2019, Science 17 Sep 2021 Vol 373, Issue 6561 pp. 1304-1306. 10.1126/science.abc3734

A robotic system for real-time analysis of inhaled submicron and microparticles, Luis G.Valerio Jr., iScience, 29 September 2021, 103091

Reevaluation of the embryonic stem cell test, RS (2013) Volume 1: Issue 1 | pages 32-49

Transcriptomic time-series analysis of early development in olive from germinated embryos to juvenile tree, BMC Genomics volume 19, Article number: 824 (2018)

Gene expression profiling of cultured mouse testis fragments treated with ethinylestradiol, J. Toxicol. Sci. Vol.44,No.10,667-679, 2019

Evaluation of Culture Time and Media in an In Vitro Testis Organ Culture System, Birth Defects Res. 2017 Apr 17;109(7):465-474.

Evaluation of an in vitro mouse testis organ culture system for assessing male reproductive toxicity, Birth Defects Res. 2019 Jan 15;111(2):70-77

Metabolomics‐based pathway changes in testis fragments treated with ethinylestradiol in vitro, Birth Defects Res. 26 July 2019

Evaluation of pyrrolizidine alkaloid-induced genotoxicity using metabolically competent TK6 cell lines, Food and Chemical Toxicology, Volume 145, November 2020, 111662

Development and Application of TK6-derived Cells Expressing Human Cytochrome P450s for Genotoxicity Testing, Toxicological Sciences, Volume 175, Issue 2, June 2020, Pages 251–265

An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs), Regul Toxicol Pharmacol. 2020 Jul;114:104662.

Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation, Regul Toxicol Pharmacol. 2020 Jun;113:104624.

Strategies for Rapid Risk Assessment of Color Additives Used in Medical Devices, Toxicol Sci. 2019 Aug 6;kfz179.

An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials, ASAIO J. 2020 Feb;66(2):183-189.

Simultaneous UHPLC-MS/MS Method of Estradiol Metabolites to Support the Evaluation of Phase-2 Metabolic Activity of Induced Pluripotent Stem Cell Derived Hepatocytes, Journal of Chromatography B, Volumes 1126–1127, 15 September 2019, 121765

Liver Microphysiological Systems for Predicting and Evaluating Drug Effects, Clin Pharmacol Ther. 2019 Jul; 106(1): 139–147.

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, Front Pharmacol. 2019; 10: 934.

Use of high-throughput enzyme-based assay with xenobiotic metabolic capability to evaluate the inhibition of acetylcholinesterase activity by organophosphorous pesticides, Toxicol In Vitro. 2019 Apr;56:93-100.

Assessment of Intestinal absorption of 3-MCPD by Caco-2 cells, Toxicology in Vitro, Volume 67, September 2020, 104887

Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development, ALTEX. 2020;37(3):365-394.

Quantifying drug-induced structural toxicity in hepatocytes and cardiomyocytes derived from hiPSCs using a deep learning method, Journal of Pharmacological and Toxicological Methods, Volume 105, September 2020, 106895

Utilization of a model hepatotoxic compound, diglycolic acid, to evaluate liver Organ-Chip performance and in vitro to in vivo concordance, Food and Chemical Toxicology, Volume 146, December 2020, 111850

In vitro and in silico genetic toxicity screening of flavor compounds and other ingredients in tobacco products with emphasis on ENDS,Journal of Applied Toxicology, First published: 13 July 2020

Predicting the mutagenic potential of chemicals in tobacco products using in silico toxicology tools, Toxicology Mechanisms and Methods Volume 30, 2020 - Issue 9, Pages 672-678.

Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices, Lab on a Chip, Issue 1, 2021

Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices, Micromachines (Basel). 2020 Oct; 11(10): 886.

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).

Ronald L.Wange, Paul C.Brown, Karen L.Davis-Bruno, Implementation of the principles of the 3Rs of animal testing at CDER: Past, present and future, Regulatory Toxicology and Pharmacology, Volume 123, July 2021, 104953

Brian J Kwee and Kyung E Sung, Engineering microenvironments for manufacturing therapeutic cells, Experimental Biology and Medicine 2021; 0: 1–12. DOI: 10.1177/15353702211026922

Knudsen TB, Fitzpatrick SC, De Abrew, et al. Predictive Toxicology for Healthy Children. Toxicol Sci 2021 Apr 12;180(2):198-211.

Richard AM, Huang R, Waidyanatha S, Shinn P, et al. The Tox21 compound library: collaborative chemistry advancing toxicology. Chem Res Toxicol. 2021 Feb 15;34(2):189-216.

Choksi N, Lebrun S, Nguyen M, et al. Validation of the OptiSafe™ eye irritation test. Cutan Ocul Toxicol. 2020 Sep;39(3):180-192.

Kleinstreuer NC, Tong W, et al. Tetko, I V. Computational toxicology. Chem. Res. Toxicol. 2020, 33, 3, 687–688.

CoMPARA: Collaborative Modeling Project for Androgen Receptor Activity by Mansouri K, Kleinstreuer N, Abdelaziz AM, et al. Environ Health Perspect 128(2),7 February 2020:027002

An evaluation framework for new approach methodologies (NAMs) for human health safety assessment by Parish ST, Aschner M, Casey W, Corvaro M, Embry MR, Fitzpatrick S, et al. Regul Toxicol Pharmacol. 2020 Apr;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, June 2020:104624.

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. 2020;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 Ocul Toxicol. 2019 Jun;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. 2019 Aug;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, July 2019:8-14.

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. 2019 Feb;93(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. 2019, 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

FDA, ICH, and the 3Rs, September 2020

Microphysiological Systems (MPS): Bridging Human and Animal Research - An FDA/CDER Perspective given by Amy Avila, PhD

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

Resources for You

Advancing Alternative Methods at FDA

FDA's Predictive Toxicology Roadmap

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