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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. 


Reevaluation of the embryonic stem cell test 

Transcriptomic time-series analysis of early development in olive from germinated embryos to juvenile tree

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

Evaluation of pyrrolizidine alkaloid-induced genotoxicity using metabolically competent TK6 cell lines

Development and Application of TK6-derived Cells Expressing Human Cytochrome P450s for Genotoxicity Testing

An FDA/CDER perspective on nonclinical testing strategies: Classical
toxicology approaches and new approach methodologies (NAMs)

Opportunities for use of one species for longer-term toxicology testing
during drug development: A cross-industry evaluation

Strategies for Rapid Risk Assessment of Color Additives Used in Medical Devices

An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials

Simultaneous UHPLC-MS/MS Method of Estradiol Metabolites to Support the Evaluation of Phase-2 Metabolic Activity of Induced Pluripotent Stem Cell Derived Hepatocytes

Liver Microphysiological Systems for Predicting and Evaluating Drug Effects

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

Use of high-throughput enzyme-based assay with xenobiotic metabolic capability to evaluate the inhibition of acetylcholinesterase activity by organophosphorous pesticides

Assessment of Intestinal absorption of 3-MCPD by Caco-2 cells

Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development

Quantifying drug-induced structural toxicity in hepatocytes and cardiomyocytes derived from hiPSCs using a deep learning method

Utilization of a model hepatotoxic compound, diglycolic acid, to evaluate liver Organ-Chip performance and in vitro to in vivo concordance

In vitro and in silico genetic toxicity screening of flavor compounds and other ingredients in tobacco products with emphasis on ENDS

Predicting the mutagenic potential of chemicals in tobacco products using in silico toxicology tools.

Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices

Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices

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.

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

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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