Significance of animal experimentation in biomedical research in the current era: Narrative review

Sachin S. Sakat Om Bagade Ganesh Mhaske Poonam Taru Milind Sagar Manisha Rastogi   

Open Access   

Published:  Jun 16, 2022


The last century has witnessed enormous advancements in the field of biomedical research. Although many factors can be attributed to this development, laboratory animals hold a significant stake in this journey. From disease modeling to finding its cure, in both academic and industry settings, animal studies are indispensable in every step currently. With the development of genetic engineering technologies, animals mimicking human conditions closely are being generated at a rapid race. However, lack of reproducibility, translation in clinical settings, and the growing objection toward morality of using animals in research has prompted the development of alternative sources as well. With advancements in computational technology and simulation-based studies, animal models are being attempted to be replaced by approaches like organs-on-chips, organoids, and artificial tissues. While most of these technologies are still in their infancy, there seems to be a long way ahead for complete replacement of animal studies by these techniques. Till then, the judicious use of animals in biomedical research seems to be the inherent part of advanced biomedical research.

Keyword:     Biomedical research animal testing animal models drug discovery animal welfare.


Sakat SS, Bagade O, Mhaske G, Taru P, Sagar M, Rastogi M. Significance of animal experimentation in biomedical research in the current era: Narrative review. J Appl Pharm Sci, 2022. Online First.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Balcombe JP, Barnard ND, Sandusky C. Laboratory routines cause animal stress. Contemp Top Lab Anim Sci, 2004; 43(6):42-51.

Baptista CVJ, Faustino-Rocha AI, Oliveira PA. Animal Models in Pharmacology: a brief history awarding the nobel prizes for physiology or medicine. Pharmacol, 2021; 106(7-8):356-68.

Barré-Sinoussi F, Montagutelli X. Animal models are essential to biological research: issues and perspectives. Future Sci OA, 2015; 1(4):FSO63.

Bracken MB. Why animal studies are often poor predictors of human reactions to exposure. J R Soc Med, 2009; 102(3):120-2.

Cheng M, Liu W, Zhang J, Zhang S, Guo Z, Liu L, Tian J, Zhang X, Cheng J, Liu Y, Deng G, Gao G, Sun L. Regulatory considerations for animal studies of biomaterial products. Bioact Mater, 2021; 11:52-6.

Guideline ICH. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3 (R2). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, European Medicines Agency, Amsterdam, The Netherlands, 2009.

CULABBR (Committee on use of laboratory animals in biomedical and behavioral research), national research council and institute of medicine. Use of laboratory animals in biomedical and behavioral research. National Academy Press, Washington, DC, 1988.

Dehkordi AN, Babaheydari FM, Chehelgerdi M, Dehkordi SR. Skin tissue engineering: wound healing based on stem-cell-based therapeutic strategies. Stem Cell Res Ther, 2019; 10(1):111-31.

Denayer T, Stöhr T, Roy MV. Animal models in translational medicine: validation and prediction. New Horiz Transl Med, 2014; 2(1):5-11.

Doke SK. Dhawale SC. Alternatives to animal testing: a review. Saudi Pharm J, 2015; 23 (3):223-9.

Elizabeth CB. The Mighty Mouse: The impact of rodents on advances in biomedical research. Mo Med, 2013; 110(3):207-11.

Everitt JI. The future of preclinical animal models in pharmaceutical discovery and development: a need to bring in cerebro to the in vivo discussions. Toxicol Pathol, 2015; 43(1):70-7.

FDA Guideline. General considerations for animal studies for medical devices; draft guidance for Industry and Food and Drug Administration Staff, 2015. Available via media/93963/download (Accessed 10 Jan 2022).

Franco NH. Animal experiments in biomedical research: a historical perspective. Animals (Basel), 2013; 3(1): 238-73.

Fontana F, Figueiredo P, Martins JP, Santos HA. Requirements for animal experiments: problems and challenges. Small, 2021; 17(15):2004182.

Freires IA, Sardi JCO, De Castro RD, Rosalen PL. Alternative animal and non-animal models for drug discovery and development: Bonus or burden? Pharm Res, 2017; 34(4):681-6.

Fry DJ. Teaching experimental design. ILAR J, 2014; 55(3):457-71.

Geller MJ, Phlegm and breath-Babylonian contributions to mericanic medicine. In: Finkel IL, Geller MJ (eds.). Disease in Babylonia. Brill, Leiden, The Netherlands, 2007.

Hajar R. Animal testing and medicine. Heart Views, 2011; 12(1):42.

Healy K. Tissue-engineered disease models. Nat Biomed Eng, 2018; 2(12):879-80.

Hickman DL, Johnson J, Vemulapalli TH, Crisler JR, Shepherd. R. Commonly used animal models. Principles of animal research for graduate and undergraduate students, Elsevier, Amsterdam, The Netherlands, pp 117-75, 2017.

Horejs C. Organ chips, organoids and the animal testing conundrum. Nat Rev Mater, 2021; 26:1-2.

Jeffrey SF, Joseph L. Categorizing biomedical research: the basics of translation. FASEB J, 2017; 31(8):3210-5.

Kabene S, Baadel S. Bioethics: a look at animal testing in medicine and cosmetics in the UK. J Med Ethics Hist Med, 2019; 12:15.

Khorramizadeh MR, Saadat F. Animal models for human disease. Anim Biotechnol, 2020; 153-71.

Khwatenge CN, Nahashon SN. Recent advances in the application of CRISPR/Cas9 gene editing system in poultry species. Front Genet, 2021; 12:627714.

Kumar V, Singh PN, Mishra B. Animal experimentation: a rational approach towards drug development. Indian J Exp Biol, 2000; 38(6):540-8.

Lewis BJB, Branch DR. Mouse models of rheumatoid arthritis for studies on immunopathogenesis and preclinical testing of Fc receptortargeting biologics. Pharmacol, 2020; 105:618-29.

Li Z, Zheng W, Wang H, Cheng Y, Fang Y, Wu F, Sun G, Sun G, Lv C, Hui, B. Application of animal models in cancer research: Recent progress and future prospects. Cancer Manag Res, 2021; 13:2455-75.

MacDonald A, Lansdowne LE. Improving drug discovery with organoid-based "Phase 0" testing. Technology Networks, London, United Kingdom, 2021.

Maehle AH, Trohler U. Animal experimentation from antiquity to the end of the eighteenth century: attitudes and arguments. In: Rupke NA (ed.). Vivisection in historical perspective. Croom Helm, London, UK, 1987.

Mignini LE, Khan KS. Methodological quality of systematic reviews of animal studies: a survey of reviews of basic research. BMC Med Res Methodol, 2006;13:6:10.

Mizoguchi A, Mizoguchi E. Animal models of IBD: linkage to human disease. Curr Opin Pharmacol, 2010; 10(5):578-87.

National Research Council. Research training in the biomedical, behavioral, and clinical research sciences. The National Academies Press, Washington, DC, 2011.

Pandey S, Dvorakova MC. Future perspective of diabetic animal models. Endocr Metab Immune Disord Drug Targets, 2020; 20(1):25-38.

Percie du Sert N, Ahluwalia A, Alam S, Avey MT, Baker M, Browne WN, Clark A, Cuthill IC, Dirnagl U, Emerson M, Garner P, Holgate ST, Howells DW, Hurst V, Karp NA, Lazic SE, Lidster K, MacCallum CJ, Macleod M, Pearl EJ, Petersen OH, Rawle F, Reynolds P, Rooney K, Sena ES, Silberberg SD, Steckler T, Würbel H. Reporting animal research: explanation and elaboration for the ARRIVE guidelines 2.0. PLoS Biol, 2020; 18(7):e3000411.

Peterson RT, Nass R, Boyd WA, Freedman JH, Dong K, Narahashi T. Use of non-mammalian alternative models for neurotoxicological study. Neurotoxicology, 2008; 29(3):546-55.

Piedrahita, JA, Williams JK. Animal models in tissue engineering. Part I. Tissue Eng Part C Methods, 2017; 23(11):641-2.

Pistollato F, Madia F, Corvi R, Munn S, Grignard E, Paini A, Worth A, Bal-Price A, Prieto P, Casati S, Berggren E, Bopp S, Zuang V. Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies. Arch Toxicol, 2021; 95(6):1867-97.

Pound P, Ritskes-Hoitinga M. Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail. J Transl Med, 2018; 16(1):304-12.

Rahman MM, Ghoshal UC, Ragunath K, Jenkins G, Rahman M, Edwards C, Hasan M, Taylor-Robinson SD. Biomedical research in developing countries: opportunities, methods, and challenges. Indian J Gastroenterol, 2020; 39(3):292-302.

Rall DP. Relevance of animal experiments to humans. Environ Health Perspect, 1979; 32:297-330.

Ranganatha N, Kuppast IJ. A review on alternatives to animal testing methods in drug development. Int J Pharm Pharm Sci, 2012; 4:28- 32.

Rappuoli R. Inner workings: 1885, the first rabies vaccination in humans. Proc Natl Acad Sci, 2014; 111(34):12273.

Ribitsch I, Baptista PM, Consiglio AL, Melotti L, Patruno M, Jenner F, Feichter ES, Dutton LC, Connolly DJ, Steenbeek FGV, Dudhia J, Penning LC. Large animal models in regenerative medicine and tissue engineering: To do or not to do. Front Bioeng Biotechnol, 2020; 8:972.

Rollin BE. Toxicology and new social ethics for animals. Toxicol Pathol, 2003; 31:128-31.

Schön MP, Manzke V, Erpenbeck L. Animal models of psoriasishighlights and drawbacks. J Allergy Clin Immunol, 2021; 147(2):439-55.

Shiomi M, Ito T, Yamada S, Kawashima S, Fan J. Development of an animal model for spontaneous myocardial infarction (WHHLMI rabbit). Arterioscler Thromb Vasc Biol, 2003; 23:1239-1244.

Smith AJ, Clutton AE, Lilley E, Kristine EAH, Brattelid T. PREPARE: guidelines for planning animal research and testing. Lab Anim, 2018; 52(2):135-41.

Simmons D. The use of animal models in studying genetic disease: Transgenesis and induced mutation. Nat Educ, 2008; 1(1):173.

Singh VP, Pratap K, Sinha J, Desiraju K, Bahal D, Kukreti R. Critical evaluation of challenges and future use of animals in experimentation for biomedical research. Int J Immunopathol Pharmacol, 2016; 29(4):551-61.

Stokes WS. Animals and the 3Rs in toxicology research and testing: The way forward. Hum Exp Toxicol, 2015; 34(12):1297-303.

Stokes WS, Marsman DS. Animal welfare considerations in biomedical research and testing; laboratory animal welfare. The American College of Laboratory Animal Medicine, Chester, NH, pp 115-40, 2014.

Swearengen JR. Choosing the right animal model for infectious disease research. Animal Model Exp Med, 2018; 1(2):100-8.

Van Norman GA. Limitations of animal studies for predicting toxicity in clinical trials: is it time to rethink our current approach? JACC Basic Transl Sci, 2019; 4(7):845-54.

Victoria AH, Samuel HG. Refinement, reduction, and replacement (3R) strategies in preclinical testing of medical devices. Toxicol Pathol, 2019; 47(3):329-38.

Von SH, The art of medicine in early Alexandria, Cambridge University Press, Cambridge, UK, 1989.

Zhang Y, Showalter AM. CRISPR/Cas9 genome editing technology: a valuable tool for understanding plant cell wall biosynthesis and function. Front. Plant Sci, 2020;11:589517.

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