Animal Testing and Stem Cell-Based Therapies Research Paper

I. Introduction

Medical research stands as an indomitable pillar of scientific progress, continually propelling the boundaries of our understanding and innovations in healthcare. Central to this trajectory is the indispensable role played by animal testing, a cornerstone in the foundation of biomedical advancement. As articulated by the American Association for Laboratory Animal Science (AALAS), animal models have long served as invaluable surrogates in the quest to decipher complex biological mechanisms, test novel pharmaceuticals, and evaluate potential treatments, thus contributing significantly to the development of life-saving therapies. Concurrently, this research paper delves into the transformative potential of stem cell-based therapies, a cutting-edge field that offers newfound promise in addressing a myriad of medical conditions, from neurodegenerative diseases to organ transplantation. As we embark on this exploration, we confront the overarching research question: How do we reconcile the ethical considerations surrounding animal testing with the compelling prospects offered by stem cell-based therapies? This paper endeavors to dissect this complex nexus, guiding readers through historical antecedents, ethical quandaries, regulatory frameworks, and future outlooks. In so doing, it aims to foster a comprehensive understanding of the interplay between these two realms, thereby illuminating the path towards responsible scientific innovation and medical progress. To facilitate this journey, the paper is structured as follows: after this introduction, we delve into the historical perspective on animal testing (Section II), followed by an exploration of the ethical considerations inherent in such practices (Section III). Subsequently, we investigate alternatives to animal testing (Section IV) before transitioning to a comprehensive analysis of stem cell-based therapies (Section V) and their intersection with animal testing in research (Section VI). We then assess the benefits and challenges posed by animal testing in the context of stem cell research (Section VII), scrutinize regulatory mechanisms (Section VIII), and envision future directions with ethical underpinnings (Section IX). Finally, we synthesize our findings and conclusions (Section X).

II. Historical Perspective on Animal Testing

The historical trajectory of animal testing in medical research traces back to ancient civilizations, where empirical observations paved the way for medical progress. The utilization of animals as research subjects can be dated as far back as 300 BCE when the Greeks, particularly Aristotle and Erasistratus, conducted vivisections on animals to gain insights into anatomy and physiology. However, it was not until the Renaissance period that systematic experimentation on animals began to take shape, with figures like Andreas Vesalius conducting groundbreaking anatomical studies on animals, laying the foundation for modern comparative anatomy. In the 19th century, the advent of anesthesia and aseptic surgery techniques revolutionized surgical procedures, allowing for more controlled and humane experimentation on animals. The landmark work of Louis Pasteur, who employed animal models to develop vaccines for rabies and anthrax, marked a watershed moment in medical research, demonstrating the critical role animals played in advancing microbiology and immunology.

Throughout this historical evolution, animal testing has been instrumental in achieving pivotal breakthroughs, such as the development of insulin to treat diabetes by Frederick Banting and Charles Best in the early 20th century, and the discovery of the polio vaccine by Jonas Salk in the mid-20th century. These milestones have not only saved countless human lives but also enhanced our understanding of diseases and their treatment.

However, this historical journey has not been devoid of ethical concerns. As the field of animal testing expanded, so did debates over the moral and ethical implications of using animals for scientific purposes. One pivotal moment was the publication of Peter Singer’s “Animal Liberation” in 1975, which catalyzed the animal rights movement and called for a reevaluation of our treatment of animals in research settings. This led to the development of ethical guidelines and regulatory frameworks aimed at ensuring the humane treatment of animals used in experiments, including the introduction of the “Three Rs” principle of Replacement, Reduction, and Refinement in animal research, as proposed by Russell and Burch in 1959. The historical journey of animal testing is a testament to its indispensable role in scientific progress, but it is also a narrative intertwined with ethical complexities and evolving societal values, which continue to shape the practice of animal testing in contemporary medical research.

III. Ethical Considerations in Animal Testing

The use of animals in scientific research has long been a subject of ethical debate, raising profound questions about the moral implications of such practices. Ethical dilemmas abound in this context, primarily revolving around the treatment, welfare, and rights of animals involved in experiments. These concerns have spurred the development of ethical frameworks aimed at mitigating harm and ensuring humane treatment.

One of the pivotal ethical principles in animal testing is that of animal welfare. This principle emphasizes the responsibility of researchers to minimize any suffering experienced by animals during experimentation. Animal welfare standards encompass aspects such as appropriate housing, nutrition, and medical care to ensure that animals are treated with respect and compassion throughout the research process.

A key ethical framework that has emerged to guide responsible animal research is the “Three Rs” principle, introduced by William Russell and Rex Burch in 1959. These Rs stand for Replacement, Reduction, and Refinement. Replacement entails seeking alternatives to animal testing whenever possible. Reduction focuses on minimizing the number of animals used in experiments to achieve scientific objectives. Refinement underscores the importance of enhancing experimental techniques and procedures to minimize pain and distress experienced by animals.

Arguments both in favor of and against animal testing have been advanced in the ongoing ethical discourse. Proponents argue that animal testing is indispensable for medical and scientific progress. It has played a crucial role in developing vaccines, understanding disease mechanisms, and testing the safety and efficacy of pharmaceuticals before they reach human trials. Without animal testing, they contend, medical breakthroughs and the development of life-saving treatments would be severely hampered.

Conversely, opponents argue that the moral cost of using animals in research is too high. They assert that animals possess inherent rights and should not be subjected to experimentation, especially when alternative methods are available. Ethical concerns include issues of autonomy, as animals cannot provide informed consent, and the potential for unnecessary suffering. Furthermore, critics question the validity of extrapolating results from animal models to humans, citing instances where promising treatments in animals did not translate to success in human trials.

The ethical considerations surrounding animal testing remain a contentious and evolving aspect of scientific research. Striking a balance between the imperative of advancing medical knowledge and the ethical responsibility to protect animals continues to challenge researchers, policymakers, and society at large. This ongoing dialogue underscores the complexity of ethical decision-making in the realm of animal research and necessitates vigilant oversight and ongoing ethical reflection.

IV. Alternatives to Animal Testing

In recent decades, the ethical and scientific concerns surrounding animal testing have driven substantial efforts to develop and implement alternatives that can offer valuable insights into biological processes and the safety and efficacy of potential treatments while reducing the reliance on animal models. This section explores the emergence of alternative methods, including in vitro models, computer simulations, and organ-on-a-chip technologies, while also critically assessing their effectiveness and limitations.

In Vitro Models

In vitro models involve studying biological processes outside of a living organism, typically using cell cultures or tissues. These models offer a high degree of control and can be tailored to mimic specific aspects of human biology. For instance, human cell lines can be cultured and exposed to test substances, allowing researchers to assess toxicity and potential therapeutic effects. While in vitro models provide valuable data and have reduced the use of animals in certain types of testing, they often lack the complexity of whole organisms, making it challenging to replicate the intricate interactions between different tissues and organs.

Computer Simulations

Computer simulations have become increasingly sophisticated, enabling researchers to model complex biological processes and interactions. Molecular dynamics simulations, for example, can provide insights into drug binding and protein interactions. These simulations can save time and resources compared to traditional animal testing. However, their effectiveness depends on the accuracy of the models and the availability of sufficient data to inform them. Simulations may not fully capture the intricacies of living systems.

Organ-on-a-Chip Technologies

Organ-on-a-chip technologies represent a promising avenue for mimicking the function of human organs in miniature, microfluidic devices. These chips contain living cells and can replicate the behavior of specific organs or tissues, such as the lung, heart, or liver. Organ-on-a-chip systems offer a middle ground between in vitro models and whole organisms, allowing researchers to observe how different organs interact in a controlled environment. While these technologies hold great potential for drug testing and disease modeling, they are still in the early stages of development and face challenges in accurately replicating the complexity of the human body.

The effectiveness of these alternatives to animal testing varies depending on the research goals and the specific questions being addressed. In some cases, these alternatives have proven highly effective and have led to important discoveries, such as the development of certain drugs. However, they also have limitations, such as their inability to replicate the systemic effects of a whole organism, which can be essential for understanding the overall safety and efficacy of treatments. Additionally, regulatory agencies often require a combination of in vitro data and animal studies before approving new drugs or therapies, reflecting the current limitations of alternative methods.

As the field of alternatives to animal testing continues to evolve, ongoing research and innovation hold the promise of reducing reliance on animal models while ensuring that scientific progress and the safety of new treatments are not compromised. The effectiveness and acceptance of these alternatives will ultimately depend on their ability to provide robust and reliable data that can inform both scientific research and regulatory decision-making.

V. Stem Cells and Regenerative Medicine

Stem cells, characterized by their unique ability to self-renew and differentiate into various cell types, have emerged as a central focus in the field of regenerative medicine. This section elucidates the definition of stem cells, their diverse types (embryonic, adult, and induced pluripotent stem cells), and their transformative potential in regenerative medicine. Additionally, it highlights examples of successful stem cell-based therapies and their profound impact on healthcare.

Definition of Stem Cells

Stem cells are undifferentiated cells with the remarkable capacity to develop into specialized cell types. There are three primary types of stem cells:

• Embryonic Stem Cells (ESCs): Derived from embryos, these pluripotent stem cells can give rise to any cell type in the human body. Their pluripotency makes them valuable for studying early developmental processes and for potential therapeutic applications.
• Adult Stem Cells: Also known as somatic or tissue-specific stem cells, these are found in various tissues and organs throughout the body. They are multipotent, meaning they can differentiate into a limited range of cell types related to their tissue of origin. Examples include hematopoietic stem cells (found in bone marrow) and neural stem cells (found in the nervous system).
• Induced Pluripotent Stem Cells (iPSCs): iPSCs are generated by reprogramming adult cells, typically using genetic or chemical techniques. They regain pluripotency and can differentiate into various cell types, making them a valuable resource for disease modeling, drug testing, and potential therapies.

Use of Stem Cells in Regenerative Medicine

Stem cells hold immense promise in regenerative medicine due to their ability to replace or repair damaged or dysfunctional tissues and organs. In regenerative medicine, stem cells are harnessed for:

• Tissue Repair and Regeneration: Stem cells can be directed to differentiate into specific cell types required for repairing injured or degenerated tissues. For example, mesenchymal stem cells have been used in orthopedic procedures to promote bone and cartilage regeneration.
• Organ Transplantation: Stem cell-derived tissues and organs, known as organoids, are being developed as potential alternatives to traditional organ transplantation. This approach aims to alleviate the shortage of donor organs and reduce transplant-related complications.
• Disease Modeling and Drug Testing: iPSCs derived from patients with genetic diseases can be used to create disease models for research and drug development. These models enable scientists to study disease mechanisms and screen potential therapies in a controlled laboratory setting.

Examples of Successful Stem Cell-Based Therapies

Stem cell-based therapies have already made significant contributions to healthcare:

• Hematopoietic Stem Cell Transplantation: Hematopoietic stem cell transplantation has been a standard treatment for blood-related disorders such as leukemia and lymphoma. It involves replacing damaged or cancerous blood-forming cells with healthy ones from a donor.
• Corneal Epithelial Stem Cell Transplantation: Stem cell therapy has restored vision in patients with corneal damage by transplanting corneal epithelial stem cells.
• Cardiac Cell Therapy: Clinical trials have explored the use of stem cells, including cardiac progenitor cells, to repair damaged heart tissue following myocardial infarction.

Stem cell-based therapies are at the forefront of regenerative medicine, offering innovative approaches to address a wide range of diseases and injuries. These therapies hold the potential to revolutionize healthcare by providing more effective and personalized treatment options. However, their development also raises ethical and regulatory considerations, which will be explored in subsequent sections of this paper.

VI. Animal Testing in Stem Cell Research

The intersection of animal testing and stem cell research represents a dynamic and multifaceted aspect of scientific inquiry. This section delves into the intricate relationship between these two domains, elucidating the role of animal models in advancing our understanding of stem cell therapies and assessing their safety and efficacy. It also presents case studies that shed light on the practical applications of animal testing in the context of stem cell research.

Exploring the Intersection

The synergy between animal testing and stem cell research arises from the need to bridge the gap between the laboratory and clinical applications of stem cell therapies. Animal models serve as critical intermediaries in this translational process, facilitating the assessment of stem cell-based treatments’ feasibility, safety, and efficacy before they progress to human trials. This intersection is underpinned by the shared objective of improving human health and addressing the myriad of diseases and conditions that stem cell therapies promise to ameliorate.

Role of Animal Models

Animal models play several indispensable roles in the study of stem cell therapies. They enable researchers to:

• Assess Safety: Before exposing humans to experimental stem cell treatments, animal testing allows for the evaluation of potential adverse effects, including tumor formation or immune rejection. This preclinical safety assessment is crucial for mitigating risks associated with stem cell therapies.
• Examine Efficacy: Animal models provide a platform for investigating whether stem cell-based interventions can effectively regenerate damaged tissues or organs. Such studies inform researchers about the therapeutic potential and optimal delivery methods of stem cells.
• Study Mechanisms: Animal testing allows researchers to delve into the mechanisms underlying stem cell therapies. By observing how stem cells interact with host tissues and modulate biological processes in animal models, scientists gain insights into the cellular and molecular mechanisms at play.

Case Studies

Several compelling case studies underscore the practical relevance of animal testing in advancing stem cell research. One notable example is the use of animal models in developing treatments for spinal cord injuries. Studies in rodents, such as mice and rats, have provided critical insights into the transplantation of neural stem cells and their potential to restore motor function and improve quality of life in paralyzed individuals. Similarly, research in non-human primates has been instrumental in assessing the safety and efficacy of stem cell-based interventions for neurodegenerative diseases like Parkinson’s and Alzheimer’s.

Moreover, animal models have been pivotal in understanding the regenerative potential of stem cells in cardiovascular disorders, diabetes, and bone and cartilage repair. These case studies exemplify the indispensable role of animal testing in advancing stem cell-based therapies toward clinical application, while also highlighting the ethical and regulatory considerations that surround such research.

The intersection of animal testing and stem cell research represents a dynamic interplay between scientific innovation and ethical responsibility. While it accelerates the development of potentially life-changing treatments, it also necessitates the careful consideration of animal welfare and the ethical dimensions of research practices. This delicate balance underscores the need for rigorous oversight and adherence to ethical guidelines in the pursuit of medical progress.

VII. Benefits and Challenges of Animal Testing in Stem Cell Research

The use of animal models in advancing stem cell-based therapies presents a complex landscape characterized by a multitude of advantages, significant challenges, and profound ethical implications. This section critically examines the interplay between these facets, shedding light on the benefits, limitations, and ethical considerations associated with relying on animal testing in the context of stem cell research.

Advantages of Animal Models

Animal testing serves as an indispensable bridge in the translational journey of stem cell-based therapies from bench to bedside. Several advantages underpin the use of animal models in this context:

• Safety Assessment: Animal models allow for comprehensive safety assessments of stem cell therapies. They provide valuable insights into potential adverse effects, immune responses, and the risk of tumorigenesis, enabling researchers to refine treatment protocols and minimize harm to human patients.
• Efficacy Evaluation: Animals offer a platform for assessing the therapeutic efficacy of stem cell-based interventions. Through in vivo studies, researchers can observe how transplanted stem cells interact with host tissues and organs, providing critical data on treatment effectiveness.
• Mechanistic Insights: Animal testing facilitates the elucidation of the underlying mechanisms of stem cell therapies. By studying how stem cells influence biological processes within living organisms, researchers gain a deeper understanding of how these therapies function at the cellular and molecular levels.

Challenges and Limitations

However, the reliance on animal testing in stem cell research is not without challenges and limitations:

• Species Differences: Variations in physiology, anatomy, and immune responses between animal models and humans can limit the translational relevance of results. The success of a therapy in animals does not guarantee similar outcomes in human patients.
• Ethical Considerations: The use of animals in research raises ethical concerns, including questions about animal welfare, suffering, and the moral justification for sacrificing animals for scientific progress. These ethical dilemmas necessitate stringent regulations and oversight.
• Translational Challenges: Despite their benefits, animal models may not fully recapitulate the complexity of human diseases and the response to stem cell therapies. This can lead to discrepancies between preclinical and clinical results.

Ethical Implications

The ethical dimensions of using animals in stem cell research demand careful consideration. Ethical concerns include the moral status of animals, the principle of minimizing harm, and the ethical necessity of using animals only when alternatives are unavailable or insufficient. Ethical oversight and adherence to guidelines such as the “Three Rs” (Replacement, Reduction, Refinement) are essential to navigate these complexities and ensure that animal testing is conducted responsibly and with the utmost regard for animal welfare.

In conclusion, the benefits of using animal testing in stem cell research are manifold, encompassing safety assessment, efficacy evaluation, and mechanistic insights. However, these advantages coexist with significant challenges related to species differences, translational limitations, and, most critically, ethical considerations. The responsible and ethical use of animal models in stem cell research necessitates a careful balancing act, as it involves harnessing the potential of these models for scientific progress while upholding the principles of animal welfare and minimizing harm. Striking this balance is essential to advance the development of stem cell-based therapies while maintaining the highest ethical standards in research and medical practice.

VIII. Regulation and Oversight

The ethical and responsible conduct of research involving both animal testing and stem cell-based therapies is underpinned by a comprehensive regulatory framework. This section outlines the key aspects of this framework, detailing the roles of institutional review boards and ethics committees in monitoring research involving animals, and highlighting recent developments in regulations that have shaped research practices in these domains.

Regulatory Framework Governing Animal Testing and Stem Cell-Based Therapies

Research involving animals and stem cell-based therapies is subject to stringent regulatory oversight in many countries. These regulations aim to ensure the ethical treatment of animals and the safety and efficacy of emerging therapies. In the United States, for instance, the Animal Welfare Act (AWA) and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals provide a legal framework for the humane treatment of animals in research. Additionally, stem cell-based therapies are subject to Food and Drug Administration (FDA) regulations, which govern their development, evaluation, and approval for clinical use.

Role of Institutional Review Boards (IRBs) and Ethics Committees

IRBs and ethics committees play pivotal roles in the oversight of research involving animals and stem cell-based therapies. IRBs are responsible for evaluating and approving research protocols to ensure they meet ethical standards and regulatory requirements. For animal research, IRBs consider factors such as the necessity of using animals, the minimization of suffering, and the ethical treatment of animals in accordance with the “Three Rs” (Replacement, Reduction, Refinement). In the case of stem cell research, ethics committees assess the ethical considerations of using human subjects, including issues related to informed consent, privacy, and the potential risks and benefits of the research.

Recent Developments in Regulations

Recent years have witnessed notable developments in the regulations governing both animal testing and stem cell-based therapies. For animal testing, there has been a growing emphasis on refinement techniques to minimize pain and distress in research animals. The development and implementation of alternatives to animal testing, such as in vitro models and computational methods, have gained traction, leading to more ethical and efficient research practices. Additionally, the refinement of animal welfare standards has been a focus of regulatory updates.

In the realm of stem cell-based therapies, regulations have become more stringent to ensure the safety and efficacy of treatments. The FDA has increased its scrutiny of stem cell clinics and unproven stem cell interventions, taking regulatory action against those operating outside established safety and efficacy parameters. These measures aim to protect patients from unverified and potentially dangerous treatments while promoting responsible stem cell research.

In summary, the regulatory landscape governing animal testing and stem cell-based therapies is designed to safeguard both the ethical treatment of animals and the welfare of human subjects. Institutional review boards and ethics committees serve as vital guardians of ethical standards in research. Recent developments in regulations reflect an evolving understanding of ethical responsibilities and the imperative to uphold the highest ethical and safety standards in research and medical practice. These regulatory advances are crucial in maintaining public trust and ensuring the responsible advancement of scientific knowledge and medical therapies.

IX. Future Directions and Ethical Considerations

The future of both animal testing and stem cell-based therapies holds promise, yet also raises complex ethical questions. This section explores potential future trends in these fields, addresses ongoing ethical debates, and presents strategies to enhance the ethical conduct of research in this dynamic and evolving area.

Future Trends in Animal Testing and Stem Cell-Based Therapies

• Advancements in Alternatives: The development and refinement of alternatives to animal testing are expected to continue. This includes the expansion of in vitro models, the enhancement of computational simulations, and the maturation of organ-on-a-chip technologies. These innovations will offer more ethical and efficient research methods.
• Precision Medicine: Stem cell-based therapies are poised to become more personalized and precise. Advancements in regenerative medicine may lead to the development of treatments tailored to individual genetic and cellular profiles, optimizing therapeutic outcomes while minimizing risks.
• Gene Editing: The convergence of stem cell research and gene editing techniques, such as CRISPR-Cas9, holds the potential to revolutionize regenerative medicine. This technology may enable the precise modification of stem cells for therapeutic purposes, opening new avenues for treating genetic diseases and degenerative conditions.

Ongoing Ethical Debates and Emerging Issues

Human-Animal Chimeras: The creation of human-animal chimeras, which involve combining human and animal cells or tissues, presents ethical dilemmas related to the moral status of these entities and the potential for unintended consequences. Addressing the ethical implications of such research will be paramount.

• Commercialization and Regulation: Stem cell clinics and companies offering unproven and potentially unsafe treatments continue to pose ethical challenges. Stricter regulation and increased public awareness are essential to protect patients from harm and ensure the responsible development of stem cell therapies.
• Transparency and Informed Consent: Ensuring transparency in stem cell research and obtaining informed consent from participants in clinical trials are ongoing ethical imperatives. The complexity of stem cell therapies and the potential for commercial exploitation demand rigorous oversight and clear communication with patients.

Enhancing Ethical Conduct of Research

• Ethics Education: Researchers and institutions should prioritize ethics education and training for scientists involved in animal testing and stem cell research. This includes raising awareness of ethical guidelines, responsible research practices, and the principles of animal welfare.
• Stakeholder Engagement: Engaging with stakeholders, including the public, patients, ethicists, and regulatory agencies, is vital to ensure that ethical considerations are thoroughly evaluated in the planning and execution of research.
• Ethics Committees: Strengthening the role and independence of ethics committees, both in animal research and stem cell research, can enhance ethical oversight. These committees should be empowered to assess ethical considerations comprehensively.
• Global Collaboration: International collaboration and harmonization of ethical standards and regulations will promote responsible research practices across borders and facilitate the exchange of knowledge and expertise.

In conclusion, the future of animal testing and stem cell-based therapies holds great potential for scientific and medical progress. However, these advancements must be pursued with a deep commitment to ethical principles and the welfare of both animals and human subjects. Addressing ongoing ethical debates, fostering transparency, and implementing robust oversight mechanisms will be essential to ensure that these fields continue to advance ethically and responsibly, benefiting society while upholding the highest ethical standards in research and medical practice.

X. Conclusion

This research paper has navigated the intricate terrain of animal testing and stem cell-based therapies, unraveling the multifaceted dimensions of these fields while addressing their ethical complexities. Summarizing the key findings and arguments presented, we have highlighted the following:

Animal testing has been an indispensable tool in medical research, allowing for the assessment of safety and efficacy in the development of various therapies and pharmaceuticals. The historical perspective has illustrated the pivotal role of animal models in advancing our understanding of diseases and treatments, contributing to significant breakthroughs in healthcare. However, this history is intertwined with ethical dilemmas and evolving ethical considerations, prompting the development of regulatory frameworks, ethical guidelines, and the promotion of alternatives to animal testing.

Stem cell-based therapies have emerged as a transformative force in medicine, holding promise for addressing a wide range of diseases and conditions. The definition of stem cells and their diverse types, including embryonic, adult, and induced pluripotent stem cells, was elucidated. Their potential in regenerative medicine, exemplified by successful therapies and disease modeling, has showcased their profound impact on healthcare.

The relationship between animal testing and stem cell research has emerged as a critical nexus for scientific progress. Animal models have played essential roles in assessing the safety and efficacy of stem cell-based therapies, providing valuable insights into mechanisms, and paving the way for clinical applications. However, this intersection is not without challenges, including species differences and ethical considerations surrounding the use of animals in research.

The ethical dimensions of both animal testing and stem cell-based therapies demand rigorous scrutiny. Ethical considerations encompass animal welfare, the principles of minimizing harm, informed consent, and responsible research practices. Striking a balance between scientific progress and ethical responsibility is essential in guiding research practices in these domains.

In conclusion, the relationship between animal testing and stem cell-based therapies underscores the significance of harmonizing scientific advancement with ethical considerations. As we navigate the future of these fields, we must remain vigilant in upholding the highest ethical standards, protecting animal welfare, and ensuring the responsible conduct of research. The profound potential of stem cell-based therapies to revolutionize healthcare must be pursued with unwavering commitment to ethical principles, recognizing that the responsible pursuit of scientific knowledge is intertwined with our ethical duty to both animals and humanity. In this dynamic interplay, ethical consciousness will continue to guide our path toward innovative, humane, and ethically sound advancements in medical research and patient care.

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