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Interagency Coordinating Committee On The Validation Of Alternative Methods
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinates U.S. federal government evaluation of new, revised, and alternative test methods. Alternative methods are methods for safety testing of chemicals and chemical products that use fewer or no animals or that minimize or prevent animal pain and distress. Establishment of ICCVAM ThICCVAM Authorization Act of 2000created ICCVAM to "establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid safety testing methods that protect human and animal health and the environment while reducing, refining, and replacing animal tests and ensuring human safety and product effectiveness". This Act addressed directives in the NIH Revitalization Act of 1993 requiring that the National Institute of Environmental Health Sciences (NIEHS) establish criteria for the validation and regulatory acceptance of alternativ ...
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Federal Government Of The United States
The federal government of the United States (U.S. federal government or U.S. government) is the national government of the United States, a federal republic located primarily in North America, composed of 50 states, a city within a federal district (the city of Washington in the District of Columbia, where most of the federal government is based), five major self-governing territories and several island possessions. The federal government, sometimes simply referred to as Washington, is composed of three distinct branches: legislative, executive, and judicial, whose powers are vested by the U.S. Constitution in the Congress, the president and the federal courts, respectively. The powers and duties of these branches are further defined by acts of Congress, including the creation of executive departments and courts inferior to the Supreme Court. Naming The full name of the republic is "United States of America". No other name appears in the Constitution, and this i ...
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United States Department Of Defense
The United States Department of Defense (DoD, USDOD or DOD) is an executive branch department of the federal government charged with coordinating and supervising all agencies and functions of the government directly related to national security and the United States Armed Forces. The DoD is the largest employer in the world, with over 1.34 million active-duty service members (soldiers, marines, sailors, airmen, and guardians) as of June 2022. The DoD also maintains over 778,000 National Guard and reservists, and over 747,000 civilians bringing the total to over 2.87 million employees. Headquartered at the Pentagon in Arlington, Virginia, just outside Washington, D.C., the DoD's stated mission is to provide "the military forces needed to deter war and ensure our nation's security". The Department of Defense is headed by the secretary of defense, a cabinet-level head who reports directly to the president of the United States. Beneath the Department of Defense are th ...
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Toxicology Organizations
Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure (whether it is acute or chronic), route of exposure, species, age, sex, and environment. Toxicologists are experts on poisons and poisoning. There is a movement for evidence-based toxicology as part of the larger movement towards evidence-based practices. Toxicology is currently contributing to the field of cancer research, since some toxins can be used as drugs for killing tumor cells. One prime example of this is ribosome-inactivating proteins, tested in the treatment of leukemia. The word ''toxicology'' () is a neoclas ...
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Consumer Protection
Consumer protection is the practice of safeguarding buyers of goods and services, and the public, against unfair practices in the marketplace. Consumer protection measures are often established by law. Such laws are intended to prevent businesses from engaging in fraud or specified unfair practices in order to gain an advantage over competitors or to mislead consumers. They may also provide additional protection for the general public which may be impacted by a product (or its production) even when they are not the direct purchaser or consumer of that product. For example, government regulations may require businesses to disclose detailed information about their products—particularly in areas where public health or safety is an issue, such as with food or automobiles. Consumer protection is linked to the idea of consumer rights and to the formation of consumer organizations, which help consumers make better choices in the marketplace and pursue complaints against businesses. ...
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Animal Welfare
Animal welfare is the well-being of non-human animals. Formal standards of animal welfare vary between contexts, but are debated mostly by animal welfare groups, legislators, and academics. Animal welfare science uses measures such as longevity, disease, immunosuppression, behavior, physiology, and reproduction, although there is debate about which of these best indicate animal welfare. Respect for animal welfare is often based on the belief that nonhuman animals are sentient and that consideration should be given to their well-being or suffering, especially when they are under the care of humans. These concerns can include how animals are slaughtered for food, how they are used in scientific research, how they are kept (as pets, in zoos, farms, circuses, etc.), and how human activities affect the welfare and survival of wild species. There are two forms of criticism of the concept of animal welfare, coming from diametrically opposite positions. One view, held by some think ...
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Institutional Animal Care And Use Committee
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB). Most research involving laboratory animals in the United States is funded by the United States National Institutes of Health or, to lesser extents, other federal agencies. The NIH Office of Laboratory Animal Welfare (OLAW) has been directed by law to develop policies that describe the role of Institutional Animal Care and Use Committees. Every institution that uses certain animals for federally funded laboratory research must have an Institutional Animal Care and Use Committee (IACUC). Each local IACUC reviews research protocols and conducts evaluations of the institution's animal ...
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Verification And Validation
Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V". In practice, as quality management terms, the definitions of verification and validation can be inconsistent. Sometimes they are even used interchangeably. However, the PMBOK guide, a standard adopted by the Institute of Electrical and Electronics Engineers (IEEE), defines them as follows in its 4th edition: * "Validation. The assurance that a product, service, or system meets the needs of the customer and other iden ...
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High-throughput Screening
High-throughput screening (HTS) is a method for scientific experimentation especially used in drug discovery and relevant to the fields of biology, materials science and chemistry. Using robotics, data processing/control software, liquid handling devices, and sensitive detectors, high-throughput screening allows a researcher to quickly conduct millions of chemical, genetic, or pharmacological tests. Through this process one can quickly recognize active compounds, antibodies, or genes that modulate a particular biomolecular pathway. The results of these experiments provide starting points for drug design and for understanding the noninteraction or role of a particular location. Assay plate preparation The key labware or testing vessel of HTS is the microtiter plate, which is a small container, usually disposable and made of plastic, that features a grid of small, open divots called ''wells''. In general, microplates for HTS have either 96, 192, 384, 1536, 3456 or 6144 wells. The ...
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Adverse Outcome Pathway
An adverse outcome pathway (AOP) is structured representation of biological events leading to adverse effects and is considered relevant to risk assessment. The AOP links in a linear way existing knowledge along one or more series of causally connected key events (KE) between two points — a molecular initiating event (MIE) and an adverse outcome (AO) that occur at a level of biological organization relevant to risk assessment. The linkage between the events is described by key event relationships (KER) that describe the causal relationships between the key events. AOPs are important for expanding the use of mechanistic toxicological data for risk assessment and regulatory applications with recent applications in further disciplines such as climate science. Background In 2012, the Organisation for Economic Co-operation and Development (OECD) launched a new programme on the development of adverse outcome pathways. A guidance document describes in detail how AOPs are to be d ...
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Endocrine Disruptors
Endocrine disruptors, sometimes also referred to as hormonally active agents, endocrine disrupting chemicals, or endocrine disrupting compounds are chemicals that can interfere with endocrine (or hormonal) systems. These disruptions can cause cancerous tumors, birth defects, and other developmental disorders. Found in many household and industrial products, endocrine disruptors "interfere with the synthesis, secretion, transport, binding, action, or elimination of natural hormones in the body that are responsible for development, behavior, fertility, and maintenance of homeostasis (normal cell metabolism)." Any system in the body controlled by hormones can be derailed by hormone disruptors. Specifically, endocrine disruptors may be associated with the development of learning disabilities, severe attention deficit disorder, cognitive and brain development problems. There has been controversy over endocrine disruptors, with some groups calling for swift action by regulators to r ...
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Pyrogens
Fever, also referred to as pyrexia, is defined as having a temperature above the normal range due to an increase in the body's temperature set point. There is not a single agreed-upon upper limit for normal temperature with sources using values between in humans. The increase in set point triggers increased muscle contractions and causes a feeling of cold or chills. This results in greater heat production and efforts to conserve heat. When the set point temperature returns to normal, a person feels hot, becomes flushed, and may begin to sweat. Rarely a fever may trigger a febrile seizure, with this being more common in young children. Fevers do not typically go higher than . A fever can be caused by many medical conditions ranging from non-serious to life-threatening. This includes viral, bacterial, and parasitic infections—such as influenza, the common cold, meningitis, urinary tract infections, appendicitis, Lassa, COVID-19, and malaria. Non-infectious causes include ...
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Allergic Contact Dermatitis
Allergic contact dermatitis (ACD) is a form of contact dermatitis that is the manifestation of an allergic response caused by contact with a substance; the other type being irritant contact dermatitis (ICD). Although less common than ICD, ACD is accepted to be the most prevalent form of immunotoxicity found in humans. By its allergic nature, this form of contact dermatitis is a hypersensitive reaction that is atypical within the population. The mechanisms by which these reactions occur are complex, with many levels of fine control. Their immunology centres on the interaction of immunoregulatory cytokines and discrete subpopulations of T lymphocytes. Signs and symptoms The symptoms of allergic contact dermatitis are very similar to the ones caused by irritant contact dermatitis, which makes the first even harder to diagnose. The first sign of allergic contact dermatitis is the presence of the rash or skin lesion at the site of exposure. Depending on the type of allergen causing it ...
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