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Toxicity Testing
Toxicology testing, also known as safety assessment, or toxicity testing, is the process of determining the degree to which a substance of interest negatively impacts the normal biological functions of an organism, given a certain exposure duration, route of exposure, and substance concentration. Toxicology testing is often conducted by researchers who follow established toxicology test protocols for a certain substance, mode of exposure, exposure environment, duration of exposure, a particular organism of interest, or for a particular developmental stage of interest. Toxicology testing is commonly conducted during preclinical development for a substance intended for human exposure. Stages of ''in silico'', ''in vitro'' and ''in vivo'' research are conducted to determine safe exposure doses in model organisms. If necessary, the next phase of research involves human toxicology testing during a first-in-man study. Toxicology testing may be conducted by the pharmaceutical industry, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
USAPHC TOX Lab (6129598147)
The U.S. Army Public Health Center (APHC) is a United States Army The United States Army (USA) is the primary Land warfare, land service branch of the United States Department of Defense. It is designated as the Army of the United States in the United States Constitution.Article II, section 2, clause 1 of th ... element headquartered at Aberdeen Proving Ground, Maryland, United States. As a forward operating agency of the United States Army Medical Command, APHC is responsible for providing technical support and expertise in the areas of preventive medicine, public health, health promotion, and Wellness (alternative medicine), wellness to military units around the globe. John Resta serves as the director. The Maryland Office of ORAU and the Oak Ridge Institute for Science and Education administers research participation programs for APHC. History Before 2015 The lineage of the APHC can be traced back to the Army Industrial Hygiene Laboratory, which was established in 1942 u ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Subcutaneous Injection
Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion. A subcutaneous injection is administered as a bolus (medicine), bolus into the subcutis, the layer of skin directly below the dermis and Epidermis (skin), epidermis, collectively referred to as the Cutis (anatomy), cutis. The instruments are usually a hypodermic needle and a syringe. Subcutaneous injections are highly effective in administering medications such as insulin, morphine, heroin, diacetylmorphine and goserelin. Subcutaneous administration may be List of medical abbreviations, abbreviated as SC, SQ, subcu, sub-Q, SubQ, or subcut. Subcut is the preferred abbreviation to reduce the risk of misunderstanding and potential errors. Subcutaneous tissue has few blood vessels and so drugs injected into it are intended for slow, sustained rates of absorption, often with some amount of depot injection, depot effect. Compared with other route of administration, routes of ad ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Children's Environmental Exposure Research Study
The Children's Environmental Exposure Research Study (or CHEERS) was a study conducted by the United States Environmental Protection Agency designed to examine how children may be exposed to pesticides and other chemicals used in U.S. households, such as phthalates, brominated flame retardants, and perfluorinated compounds (PFOS, PFOA, PFNA, and others). The two-year study began in the summer of 2004 and was conducted in Duval County, Florida, a region with high concentration of pesticides. On April 8, 2005, Stephen L. Johnson cancelled the study after the program was criticized. Johnson himself was heavily criticized for his support in the use of human test subjects during his tenure as EPA's Assistant Administrator for Toxic Substances. Mechanics of the study The study was due to be completed in two years, researchers would follow the progress of 60 young children whose parents sprayed pesticides frequently. They would collect data every six months taken from biological sampl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Animal Testing
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of animals, as model organisms, in experiments that seek answers to scientific and medical questions. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments, and commercial facilities that provide animal-testing services to the industry. The focus of animal testing varies on a continuum from Basic research, pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some questions of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research, and Toxicology testing, toxicology, including Testing cosmetics ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Laboratory Practice
The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical (non-pharmaceutical) health and environmental safety–or simply toxicology–studies are planned, conducted, monitored, recorded, reported, and archived. These principles apply to the toxicity testing of chemicals in commerce, to ensure the quality and integrity of the safety data submitted by manufacturers to regulatory authorities globally. History The historical events leading to the proposal of the Good Laboratory Practice (GLP) regulations are crucial for understanding why these regulations are important to improve the quality and integrity of chemical safety data. They were developed in response to concerns about the reliability of toxicity data from industry. The GLP regulations aim to standardize procedures and practices to ensure accurate, reliable, and traceable safety data. GLP was first introd ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or, especially in the case of device, for the modification of physiological disorder function. In 2010, the European Union expanded PV to include medication errors such as overdose, misuse, and abuse of a drug as well as drug exposure during pregnancy and breastfeeding. These are monitored even in the absence of an adverse event, because they may result in an adve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease symptoms. Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment. Description The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies (clinical trials) or observational studies on human participants. Clinical research can cover any medical method or product from it ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pre-clinical Development
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals. The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics. Companies use stylized statistics to illustrate the risks in preclinical research, such as that on average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug. Types Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics (what the drug does to the body) (PD), pharmacokinetics (what the body does to th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Outsourcing
Outsourcing is a business practice in which companies use external providers to carry out business processes that would otherwise be handled internally. Outsourcing sometimes involves transferring employees and assets from one firm to another. The term ''outsourcing'', which came from the phrase ''outside resourcing'', originated no later than 1981 at a time when industrial jobs in the United States were being moved overseas, contributing to the economic and cultural collapse of small, industrial towns. In some contexts, the term smartsourcing is also used. The concept, which ''The Economist'' says has "made its presence felt since the time of the Second World War", often involves the contracting out of a business process (e.g., payroll processing, claims processing), operational, and/or non-core functions, such as manufacturing, facility management, call center/call center support. The practice of handing over control of public services to private enterprises ( privatiz ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
