Abstract
Pre-clinical research involving laboratory animals is a foundational component of biomedical and pharmaceutical sciences. It provides essential information on pharmacodynamics, pharmacokinetics, toxicity, and efficacy of new chemical entities before their progression to human clinical trials. Despite advances in alternative methods, animal models remain indispensable for understanding complex biological interactions at the whole-organism level. This review comprehensively discusses the principles of preclinical animal research, ethical considerations with special emphasis on the 3Rs (Replacement, Reduction, and Refinement), regulatory frameworks with focus on CPCSEA and IAEC guidelines in India, classification and selection of laboratory animals, housing and welfare requirements, experimental design, common techniques, alternatives to animal use, limitations, translational challenges, and future perspectives
The question of how animal studies should be designed, conducted, and analyzed remains underexposed in societal debates on animal experimentation. This is not only a scientific but also a moral question. After all, if animal experiments are not appropriately designed, conducted, and analyzed, the results produced are unlikely to be reliable and the animals have in effect been wasted. In this article, we focus on one particular method to address this moral question, namely systematic reviews of previously performed animal experiments. We discuss how the design, conduct, and analysis of future (animal and human) experiments may be optimized through such systematic reviews. In particular, we illustrate how these reviews can help improve the methodological quality of animal experiments, make the choice of an animal model and the translation of animal data to the clinic more evidence-based, and implement the 3Rs. Moreover, we discuss which measures are being taken and which need to be taken in the future to ensure that systematic reviews will actually contribute to optimizing experimental design and thereby to meeting a necessary condition for making the use of animals in these experiments justified.