Use Of Animals In Testing Research Articles

Primary Bone Tumors and Breast Cancer-Induced Bone Metastases: In Vivo Animal Models and New Alternative Approaches

Bone is the preferential site of metastasis for the most common tumors, including breast cancer. On the other hand, osteosarcoma is the primary bone cancer that most commonly occurs and causes bone cancer-related deaths in children. Several treatment strategies have been developed so far, with little or no efficacy for patient survival and with the development of side effects. Therefore, there is an urgent need to develop more effective therapies for bone primary tumors and bone metastatic disease. This almost necessarily requires the use of in vivo animal models that better mimic human pathology and at the same time follow the ethical principles for the humane use of animal testing. In this review we aim to illustrate the main and more suitable in vivo strategies employed to model bone metastases and osteosarcoma. We will also take a look at the recent technologies implemented for a partial replacement of animal testing.

Pioneering bioinformatics with agent-based modelling: an innovative protocol to accurately forecast skin or respiratory allergic reactions to chemical sensitizers.

The assessment of theallergenic potential of chemicals, crucial for ensuring public health safety, faces challenges in accuracy and raises ethical concerns due to reliance on animal testing. This paper presents a novel bioinformatic protocol designed to address the critical challenge of predicting immune responses to chemical sensitizers without the use of animal testing. The core innovation lies in the integration of advanced bioinformatics tools, including the Universal Immune System Simulator (UISS), which models detailed immune system dynamics. By leveraging data from structural predictions and docking simulations, our approach provides a more accurate and ethical method for chemical safety evaluations, especially in distinguishing between skin and respiratory sensitizers. Our approach integrates a comprehensive eight-step process, beginning with the meticulous collection of chemical and protein data from databases like PubChem and the Protein Data Bank. Following data acquisition, structural predictions are performed using cutting-edge tools such as AlphaFold to model proteins whose structures have not been previously elucidated. This structural information is then utilized in subsequent docking simulations, leveraging both ligand-protein and protein-protein interactions to predict how chemical compounds may trigger immune responses. The core novelty of our method lies in the application of UISS-an advanced agent-based modelling system that simulates detailed immune system dynamics. By inputting the results from earlier stages, including docking scores and potential epitope identifications, UISS meticulously forecasts the type and severity of immune responses, distinguishing between Th1-mediated skin and Th2-mediated respiratory allergic reactions. This ability to predict distinct immune pathways is a crucial advance over current methods, which often cannot differentiate between the sensitization mechanisms. To validate the accuracy and robustness of our approach, we applied the protocol to well-known sensitizers: 2,4-dinitrochlorobenzene for skin allergies and trimellitic anhydride for respiratory allergies. The results clearly demonstrate the protocol's ability to differentiate between these distinct immune responses, underscoring its potential for replacing traditional animal-based testing methods. The results not only support the potential of our method to replace animal testing in chemical safety assessments but also highlight its role in enhancing the understanding of chemical-induced immune reactions. Through this innovative integration of computational biology and immunological modelling, our protocol offers a transformative approach to toxicological evaluations, increasing the reliability of safety assessments.

Lessons for the Future of NAMs from History, Philosophy and Social Studies of Science.

This paper explores what we can learn from the humanities and social sciences about how standards operate in and around science, in order to understand more about how 'the gold standard' can be shifted away from the use of animals in research and testing, and toward New Approach Methodologies (NAMs). These fields allow us to consider potential futures of NAMs as alternatives, replacements, or complements to animal use in testing and research. As we demonstrate, the questions that we pose and how they are framed are as important as the answers that result. Rather than asking how to 'redefine the gold standard', norms and expectations for NAMs must be actively debated and transparently defined. These considerations would be based, in part, on what has been learned in the past from non-human animal models and systems, but also use the norms within the fields from which the NAMs derive in light of the rich broader contexts within which they are being developed. As we argue, notions such as 'a gold standard' are limited and must be replaced by contextualised standards that depend on the scientific, sociocultural and other factors that contribute to our understanding of a particular method (new or otherwise) as 'good' for a particular purpose.

An insight into carcinogenic activity and molecular mechanisms of Bis(2-ethylhexyl) phthalate.

Di(ethylhexyl) phthalate (DEHP) is a ubiquitous environmental contaminant to which humans are exposed via multiple routes. Human health risk assessments for this substance have recently been updated, focusing on reproductive toxicity, including DEHP, in the list of chemicals classified as carcinogenic, mutagenic, or toxic to reproduction (CMR). Moreover, DEHP has also been defined as probably and possibly carcinogenic to humans based on its carcinogenicity in rodents. However, the mechanism of action of DEHP and its relevance in humans remain unclear. Rodent data suggests that DEHP induces cancer through non-genotoxic mechanisms related to multiple molecular signals, including PPARα activation, perturbation of fatty acid metabolism, induction of cell proliferation, decreased apoptosis, production of reactive oxygen species, and oxidative stress. According to the DEHP toxicological dataset, several in vitro cell transformation assays have been performed using different protocols and cellular models to produce different results. This study aimed to evaluate the carcinogenic potential of DEHP by using the A31-1-1 BALB/c-3T3 cell line in a standard cell transformation assay. Additionally, transcriptomic analysis was performed to explore the molecular responses and identify the affected toxicological pathways. Although DEHP treatment did not induce transformation in BALB/c-3T3 cells, the transcriptomic results revealed significant modulation of several pathways associated with DEHP metabolism, tissue-specific functions related to systemic metabolism, and basal cellular signaling with pleiotropic outcomes. Among these signaling pathways, modulation of cell-regulating signaling pathways, such as Notch, Wnt, and TGF-β, can be highlighted. More specific modulation of such genes and pathways with double functions in metabolism and neurophysiology underlies the well-known crosstalk that may be crucial for the mechanism of action of DEHP. Our findings offer evidence to support the notion that these models are effective in minimizing the use of animal testing for toxicity assessment.

Criminalization Policy of Animal Testing in Cosmetics Production in Indonesia

The purpose of this study is to analyze the importance of criminalization in the use of animal testing in the production of cosmetics in Indonesia as well as the right formulation in the formation of policies on animal testing. The problem is why a criminalization policy is needed against producers who conduct animal testing as a product test in the cosmetics production process and how the formulation of criminalization arrangements against producers who conduct animal testing as a test of cosmetics products in the production process. To be able to answer the formulation of the problem, the research used is normative juridical research with a statutory approach and a comparative approach and conceptual approach. The results show that in conducting animal testing there is the concept of 3R (Replacement, Reduction and Refinement). The 3R concept is an ethic that can be used to realize an experiment by looking for possible alternatives. Because many cosmetic companies are competing in creating new innovations in order to meet the needs of consumers, so that not a few companies carry out the innovation process carried out by related parties in developing their products still often use animals for product trials, which in practice this reaps many cons both from an ethical and scientific perspective. For this reason, criminalization is needed with the existence of legal policies, especially criminal law policies with formulations that regulate starting from the procedure for conducting animal tasting, what animals can be used as animal tasting, and what the procedure is after conducting animal testing, and of course whether it is necessary to submit an application to the competent authority before conducting animal testing, finally that in a legislation also regulates how sanctions / penalties are given to everyone who deliberately violates these laws and regulations.

Report of the First ONTOX Stakeholder Network Meeting: Digging Under the Surface of ONTOX Together With the Stakeholders.

The first Stakeholder Network Meeting of the EU Horizon 2020-funded ONTOX project was held on 13-14 March 2023, in Brussels, Belgium. The discussion centred around identifying specific challenges, barriers and drivers in relation to the implementation of non-animal new approach methodologies (NAMs) and probabilistic risk assessment (PRA), in order to help address the issues and rank them according to their associated level of difficulty. ONTOX aims to advance the assessment of chemical risk to humans, without the use of animal testing, by developing non-animal NAMs and PRA in line with 21st century toxicity testing principles. Stakeholder groups (regulatory authorities, companies, academia, non-governmental organisations) were identified and invited to participate in a meeting and a survey, by which their current position in relation to the implementation of NAMs and PRA was ascertained, as well as specific challenges and drivers highlighted. The survey analysis revealed areas of agreement and disagreement among stakeholders on topics such as capacity building, sustainability, regulatory acceptance, validation of adverse outcome pathways, acceptance of artificial intelligence (AI) in risk assessment, and guaranteeing consumer safety. The stakeholder network meeting resulted in the identification of barriers, drivers and specific challenges that need to be addressed. Breakout groups discussed topics such as hazard versus risk assessment, future reliance on AI and machine learning, regulatory requirements for industry and sustainability of the ONTOX Hub platform. The outputs from these discussions provided insights for overcoming barriers and leveraging drivers for implementing NAMs and PRA. It was concluded that there is a continued need for stakeholder engagement, including the organisation of a 'hackathon' to tackle challenges, to ensure the successful implementation of NAMs and PRA in chemical risk assessment.

Retrospective analysis of dog study data from food and color additive petitions

As part of the US FDA CFSAN's efforts to explore alternatives to animal testing, we retrospectively analyzed a sample of food additive (FAP) and color additive petitions (CAP) submitted to the FDA for the utility of dog study data in safety assessment. FAPs and CAPs containing dog studies (161 petitions) were classified as decisive (38%), supportive (27%), supplemental (29%) or undermined (6%) based on the impact the dog study data had on the final safety decision. Petitions classified as decisive were further categorized based on if the dog study data were used to a) address a safety concern (35/61); b) calculate an acceptable daily intake (ADI) (11/61); c) withdraw a petition (4/61); d) the effect was unique to the dog (2/61); or e) unclear (9/61). Of 11 petitions where the dog study was used to set an ADI, 7 contained studies where the points of departure (POD) from the dog studies were within an 8-fold range of the rodent with differences in study design likely contributing to the difference in PODs. Future research should include the development and use of qualified alternative studies to replace the use of animal testing for food and color additive safety assessment while ensuring human safety.

Non-invasive assessment of hair regeneration in androgenetic alopecia mice in vivo using two-photon and second harmonic generation imaging.

The identification of crucial targets for hair regrowth in androgenetic alopecia (AGA) involves determining important characteristics and different stages during the process of hair follicle regeneration. Traditional methods for assessing key features and different stages of hair follicle primarily involve taking skin tissue samples and determining them through various staining or other methods. However, non-invasive assessment methods have been long sought. Therefore, in this study, endogenous fluorescence signals from skin keratin and second harmonic signals from skin collagen fibers were utilized as probes, two-photon excited fluorescence (TPEF) and second harmonic generation (SHG) imaging techniques were employed to non-invasively assess hair shafts and collagen fibers in AGA mice in vivo. The TPEF imaging technique revealed that the alternation of new and old hair shafts and the different stages of the growth period in AGA mice were delayed. In addition, SHG imaging found testosterone reduced hair follicle area and miniaturized hair follicles. The non-invasive TPEF and SHG imaging techniques provided important methodologies for determining significant characteristics and different stages of the growth cycle in AGA mice, which will facilitate future non-invasive assessments on human scalps in vivo and reduce the use of animal testing.

Study of Elastin, Hydrolyzed Collagen and Collagen-like Products in a Tri-Layered Chitosan Membrane to Test Anti-Aging Skin Properties.

The use of animal testing in the cosmetic industry is already prohibited in more than 40 countries, including those of the EU. The pressure for it to be banned worldwide in the future is increasing, so the need for animal alternatives is of great interest today. In addition, using animals and humans in scientific research is ethically reprehensible. This study aimed to prove some of the anti-aging properties of elastin (EL), hydrolyzed collagen (HC), and two vegan collagen-like products (Veg Col) in a tri-layered chitosan membrane that was ionically crosslinked with sodium tripolyphosphate (TPP). In the first approach, as a way of representing different layers of a biological system, such as the epidermis and the two dermis sublayers, EL, HC, or Veg Col were independently introduced into the two inner layers (2L(i+b)). Their effects were compared with those of their introduction into three layers (3L). Different experiments were performed on the membrane to test its elasticity, hydration, moisture retention, and pore reduction at different concentrations of EL, HC, and Veg Col, and the results were normalized vs. a blank membrane. This new alternative to animal or human testing can be suitable for proving certain efficacy claims for active ingredients or products in the pharmaceutical, nutritional, and cosmetic fields.

Animal Alternatives for Drug Development

Animal Alternatives for Drug Development

Access to public information regarding laboratory animals: law and ethics

Normative regulations concerning the use of animals in experiments and education raise numerous controversies and much social discussion. One of the aspects of implementing this form of social activity is the use of constitutional, subjective right of access to public information. Competent public administration authorities, and administrative courts encounter numerous difficulties related to requests for information. Attempts to assess, evaluate, and verify whether the applicants’ goals and intentions are consistent with the axiological premises of the statutory norms occur. The study reveals veterinary, legal, and moral aspects of requests for access to public information related to the use of animals in testing and teaching procedures. The controversial concept of abuse/misuse of the subjective right to access information is presented in a critical, multifaceted way. Obligations of professional ethics of veterinary surgeons concerning laboratory animals and public information related to them are discussed. The effectiveness and consistency of normative regulations are assessed. Interpretational postulates are indicated.

Alternative Methods for Skin-Sensitization Assessment.

Skin sensitization is a term used to refer to the regulatory hazard known as allergic contact dermatitis (ACD) in humans or contact hypersensitivity in rodents, an important health endpoint considered in chemical hazard and risk assessments. Information on skin sensitization potential is required in various regulatory frameworks, such as the Directive of the European Parliament and the Council on Registration, Evaluation and Authorization of Chemicals (REACH). The identification of skin-sensitizing chemicals previously required the use of animal testing, which is now being replaced by alternative methods. Alternative methods in the field of skin sensitization are based on the measurement or prediction of key events (KE), i.e., (i) the molecular triggering event, i.e., the covalent binding of electrophilic substances to nucleophilic centers in skin proteins; (ii) the activation of keratinocytes; (iii) the activation of dendritic cells; (iv) the proliferation of T cells. This review article focuses on the current state of knowledge regarding the methods corresponding to each of the key events in skin sensitization and considers the latest trends in the development and modification of these methods.

Natural language processing in toxicology: Delineating adverse outcome pathways and guiding the application of new approach methodologies

Adverse Outcome Pathways (AOPs) are conceptual frameworks that tie an initial perturbation (molecular initiating event) to a phenotypic toxicological manifestation (adverse outcome), through a series of steps (key events). They provide therefore a standardized way to map and organize toxicological mechanistic information. As such, AOPs inform on key events underlying toxicity, thus supporting the development of New Approach Methodologies (NAMs), which aim to reduce the use of animal testing for toxicology purposes.However, the establishment of a novel AOP relies on the gathering of multiple streams of evidence and information, from available literature to knowledge databases. Often, this information is in the form of free text, also called unstructured text, which is not immediately digestible by a computer. This information is thus both tedious and increasingly time-consuming to process manually with the growing volume of data available. The advancement of machine learning provides alternative solutions to this challenge. To extract and organize information from relevant sources, it seems valuable to employ deep learning Natural Language Processing techniques.We review here some of the recent progress in the NLP field, and show how these techniques have already demonstrated value in the biomedical and toxicology areas. We also propose an approach to efficiently and reliably extract and combine relevant toxicological information from text. This data can be used to map underlying mechanisms that lead to toxicological effects and start building quantitative models, in particular AOPs, ultimately allowing animal-free human-based hazard and risk assessment.

PHASE 0 CLINICAL TRIAL: HOPE THROUGH RESEARCH

This paper Development of a drug molecule has always been a long and an exclusive process. From preclinical to clinical testing, it takes almost 10-15 years with an expense of almost US$2 Billion. It has been observed that serious challenges faced by researchers resulting in highest rate of failure in development of new drug molecules in clinical research. Seeing these grievances, the US FDA in 2004 introduced a “Critical Path “document highlighting the major decline of the drug development process despite having new advances and technology in biomedical research and the majors to improve the quality and effectiveness of overall drug discovery and development process. Thus, in 2006 a new guidance was issued on Exploratory IND studies by US FDA which is called phase 0 clinical study. It uses the concept of micro dosing. Minimum 30-40% of drugs fail in phase 1 trial due to unfavorable pk and pd. Micro-dosing is a new toolkit used in the drug development process and includes low or minute intake of molecules hardly to show any pharmacological effect when administered by participants and thus, helps in evaluating pk profiles. It shows no therapeutic effect, so chances of adverse reactions are also low. It acts as a bridge between preclinical and clinical study and can be beneficial in reducing extensive use of animal testing. Human screening is conducted to enroll few healthy participants for minimal no. of 7 days for the conduction of phase 0 trial. With recent technology, research and development and advancement, micro dosing has become more and more revolutionary and is emerging as the dormant challenge to be enormously used in more and more drug development process and make a shift to the process in a positive direction. The First emerging development of phase 0 trial can be witnessed in successful oncology trial in patients with progressive malignancies. Results proved to show a good and a well-tolerated bioavailability, and a desirable pharmacokinetics and biochemical data and hence this evidence can be used further to guide the development process and improve the drug development scenario.

Artificial Intelligence-Based Toxicity Prediction of Environmental Chemicals: Future Directions for Chemical Management Applications.

Recently, research on the development of artificial intelligence (AI)-based computational toxicology models that predict toxicity without the use of animal testing has emerged because of the rapid development of computer technology. Various computational toxicology techniques that predict toxicity based on the structure of chemical substances are gaining attention, including the quantitative structure-activity relationship. To understand the recent development of these models, we analyzed the databases, molecular descriptors, fingerprints, and algorithms considered in recent studies. Based on a selection of 96 papers published since 2014, we found that AI models have been developed to predict approximately 30 different toxicity end points using more than 20 toxicity databases. For model development, molecular access system and extended-connectivity fingerprints are the most commonly used molecular descriptors. The most used algorithm among the machine learning techniques is the random forest, while the most used algorithm among the deep learning techniques is a deep neural network. The use of AI technology in the development of toxicity prediction models is a new concept that will aid in achieving a scientific accord and meet regulatory applications. The comprehensive overview provided in this study will provide a useful guide for the further development and application of toxicity prediction models.

Development of a Vitrification Preservation Process for Bioengineered Epithelial Constructs.

The demand for human bioengineered tissue constructs is growing in response to the worldwide movement away from the use of animals for testing of new chemicals, drug screening and household products. Presently, constructs are manufactured and delivered just in time, resulting in delays and high costs of manufacturing. Cryopreservation and banking would speed up delivery times and permit cost reduction due to larger scale manufacturing. Our objective in these studies was development of ice-free vitrification formulations and protocols using human bioengineered epithelial constructs that could be scaled up from individual constructs to 24-well plates. Initial experiments using single EpiDerm constructs in vials demonstrated viability >80% of untreated control, significantly higher than our best freezing strategy. Further studies focused on optimization and evaluation of ice-free vitrification strategies. Vitrification experiments with 55% (VS55) and 70% (VS70) cryoprotectant (CPA) formulations produced constructs with good viability shortly after rewarming, but viability decreased in the next days, post-rewarming in vitro. Protocol changes contributed to improved outcomes over time in vitro. We then transitioned from using glass vials with 1 construct to deep-well plates holding up to 24 individual constructs. Construct viability was maintained at >80% post-warming viability and >70% viability on days 1–3 in vitro. Similar viability was demonstrated for other related tissue constructs. Furthermore, we demonstrated maintenance of viability after 2–7 months of storage below −135 °C.

Chemical Screening in an Estrogen Receptor Transactivation Assay With Metabolic Competence.

The U.S. EPA continues to utilize high-throughput screening data to evaluate potential biological effects of endocrine active substances without the use of animal testing. Determining the scope and need for in vitro metabolism in high-throughput assays requires the generation of larger data sets that assess the impact of xenobiotic transformations on toxicity-related endpoints. The objective of the current study was to screen a set of 768 ToxCast chemicals in the VM7Luc estrogen receptor transactivation assay (ERTA) using the Alginate Immobilization of Metabolic Enzymes hepatic metabolism method. Chemicals were screened with or without metabolism to identify estrogenic effects and metabolism-dependent changes in bioactivity. Based on estrogenic hit calls, 85 chemicals were active in both assay modes, 16 chemicals were only active without metabolism, and 27 chemicals were only active with metabolism. Using a novel metabolism curve shift method that evaluates the shift in concentration-response curves, 29 of these estrogenic chemicals were identified as bioactivated and 59 were bioinactivated. Human biotransformation routes and associated metabolites were predicted in silico across the chemicals to mechanistically characterize possible transformation-related ERTA effects. Overall, the study profiled novel chemicals associated with metabolism-dependent changes in ERTA bioactivity, and suggested routes of biotransformation and putative metabolites responsible for the observed estrogenic effects. The data demonstrate a range of metabolism-dependent effects across a diverse chemical library and highlight the need to evaluate the role of intrinsic xenobiotic metabolismfor endocrine and other toxicity-related health effects.

A tiered approach to risk assess microbiome perturbations induced by application of beauty and personal care products

In the consumer goods sector, there is a rapid increase in launches of products that affect the human microbiome. Whilst more and more studies and product claims focus on the health benefits of the manipulation of microbiomes, ensuring that perturbations of the microbiome by the application of beauty and personal care products do not have potential unwanted consequences on the health of consumers is less well described in the scientific literature. There is currently no agreement on approaches to assess the possible impacts on consumer safety nor quantitatively defined endpoints of concern. We propose a 3-tier framework to qualitatively assess the potential impact of skin and oral microbiome perturbations on consumer health. The framework is established in accordance with the next generation risk assessment principles used in toxicology and avoids the use of animal testing. It was developed using a collaborative consultation including oral and skin microbiome experts, bioinformaticians and microbiological risk assessors. The first tier is based on a “history of safe use” concept, where the efficacy of a bioactive of interest is benchmarked against formulations generally regarded as safe because of their long history of consumer use. One of the endpoints identified during the development of the approach is that the microbiome's resilience is not compromised, that is its capacity to respond to challenges without going to dysbiosis. Therefore, the second tier is based on the notion of microbiome stability and its resilience to short term perturbations. The third tier aims to utilise next generation sequencing data and relate these to health status. Whilst 16S rRNA data have brought unprecedented resolution in determining the species present in microbiomes, we illustrate the challenges associated with predicting potential consequences for consumer health and disease from this type of data in a case study. With the development of whole genome sequencing technology and progress with integration of -omics data, we propose that the active functions of the microbiome rather than taxonomic classification should be the basis of a safety assessment. We suggest a research strategy to define the potential endpoints of concern quantitatively, based on a concomitant development of in vitro 3D tissue models in which the host response can be assessed, in silico approaches to describe the microbiome and longitudinal human studies to validate learnings in situ.

Workshop Pengisian Formulir Etik Penelitian Pada Hewan Coba Di Fakultas Kedokteran Universitas Baiturrahmah

Controversy over the use of test animals is common. Researchers sometimes say the test animal is just an animal, so researchers forget that animals also have the right not to feel pain and be free from torture. For the creation of an ideal treatment for test animals, researchers should pay attention to the ethics of surgery and follow the ethical guidelines of health research. This study aims to find out the picture of the application of ethical forms on animals at the Faculty of Animal Investigation Baiturrahmah University. The research method used is descriptive. The study was conducted by baiturrahamh medical students in Padang city with 80 people. The study measuring tool uses a google form questionnaire—processing data with excel. The results obtained the most answer the example of treatment that meets freedom from Hunger and thirst is to provide appropriate feed to animals try as many as 72 people (90%), most answers about the placement of animals try in a room that is light enough, large cages accordingly so that animals try to be comfortable is a treatment is freedom from discomfort that is 70 people (87.5%) and most answer about the three basic principles of ethical research in animals try is respect. That is 54 people (67.5%). The conclusion was obtained that the example of treatment that meets freedom from Hunger and thirst is to provide appropriate feed to the animal try, the placement of the animal tries in a room that is light enough, large cages accordingly so that animals try to be comfortable is a treatment is freedom from discomfort and about the three basic principles of ethical research in animals try is respect

Coupled experimental and computational approach to stomach biomechanics: Towards a validated characterization of gastric tissues mechanical properties

Gastric diseases are one of the most relevant healthcare problems worldwide. Interventions and therapies definition/design mainly derive from biomedical and clinical expertise. Computational biomechanics, with particular regard to the finite element method, provides hard-to-measure quantities during in-vivo tests, such as strain and stress distribution, leading to a more comprehensive and promising approach to improve the effectiveness of many different clinical activities. However, reliable finite element models of biological organs require appropriate constitutive formulations of building tissues, whose parameters identification needs an experimental campaign consisting in different tests on human tissues and organs. The aim of the reported here research activities was the identification of mechanical properties of human gastric tissues. Human gastric specimens were tested at tissue, sub-structural and structural levels, by tensile, membrane indentation and inflation tests, respectively. On the other hand, animal experimentations on tissue layers from literature pointed out the mechanical response at sub-tissue level during tensile loading conditions. In detail, the analysis of experimental results at sub-tissue and tissue levels led to a fibre-reinforced visco-hyperelastic constitutive formulation and to the identification of gastric layers mechanical behaviour. Results from experimentations on human samples were coupled with data derived from animal models. Data from sub-structural and structural experimentations were exploited to upgrade and validate the constitutive formulations and parameters. The developed investigations led to a reliable constitutive framework of human gastric tissues that both describe stomach mechanical functionality and allow computational investigations. Indeed, the comparisons among average computational data and experimental medians provided the following RMSEs (Root Mean Square Errors): 0.89 N, 0.15 N for corpus and fundus during membrane indentation test, respectively, and 0.44 kPa during inflation test. Accounting for the magnitude of experimental and computational data, the RMSEs can be considered low and acceptable because they concerned biological samples. In fact, biological tissues and structures are affected by a high inherent inter-samples’ variability, which is detectable in both the geometrical configuration and the mechanical behaviour. The specific values of the here reported RMSEs ensured the reliability of the achieved parameters and the quality of the overall developed procedure.Reliable computational models of the gastric district could become efficient clinical tools to find out the main crucial aspects of bariatric procedures, such as the mechanical stimulation of gastric mechano-receptors. Moreover, the methods of computational biomechanics will permit to run the preliminary tests of new and innovative bariatric procedures, on one hand, predicting the successful rate and the effectiveness, and, on other hand, reducing the use of animal testing.