1.
Food and Drug Administration
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The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. As of 2017, 3/4th of the FDA budget is funded by the pharmaceutical companies due to the Prescription drug user fee act and these include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice, the Commissioner reports to the Secretary of Health and Human Services. Dr. Robert M. Califf, MD is the current commissioner, who took over in February 2016 for Dr. Stephen Ostroff, the FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, in 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. The site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak, the first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. Only one original building from the facility was kept. All other buildings are new construction, the project is slated to be completed by 2017, assuming future Congressional funding While most of the Centers are located in the Washington, D. C. The Office of Regulatory Affairs is considered the eyes and ears of the agency, the Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based roughly on the divisions of the federal court system. Each district comprises a main office and a number of Resident Posts. ORA also includes the Agencys network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, the Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and dont focus on aspects of the regulated industries. In many cases, OCI pursues cases involving Title 18 violations, OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, OCI is a smaller branch, comprising about 200 agents nationwide. The FDA frequently works with federal agencies, including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection. Often local and state government agencies also work with the FDA to provide regulatory inspections, the FDA regulates more than US$1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States
2.
Feces
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Feces or faeces are the solid or semisolid metabolic waste from an animals digestive tract, discharged through the anus or cloaca during a process called defecation. Urine and feces together are called excreta, collected feces has various uses, namely as fertilizer or soil conditioner in agriculture, as a fuel source, or for medicinal purposes. After an animal has digested eaten material, the remains of material are discharged from its body as waste. Although it is lower in energy than the food from which it is derived, feces may retain a large amount of energy and this means that of all food eaten, a significant amount of energy remains for the decomposers of ecosystems. Many organisms feed on feces, from bacteria to fungi to insects such as dung beetles, some may specialize in feces, while others may eat other foods as well. Feces serve not only as a food, but also as a supplement to the usual diet of some animals. Feces and urine, which reflect light, are important to raptors such as kestrels. Seeds also may be found in feces, animals who eat fruit are known as frugivores. An advantage for a plant in having fruit is that animals will eat the fruit and this mode of seed dispersal is highly successful, as seeds dispersed around the base of a plant are unlikely to succeed and often are subject to heavy predation. Provided the seed can withstand the pathway through the system, it is not only likely to be far away from the parent plant. This cycling of matter is known as the biogeochemical cycle, the distinctive odor of feces is due to bacterial action. Gut flora produce compounds such as indole, skatole, and thiols and these are the same compounds that are responsible for the odor of flatulence. Consumption of foods prepared with spices may result in the spices being undigested, the perceived bad odor of feces has been hypothesized to be a deterrent for humans, as consuming or touching it may result in sickness or infection. Human perception of the odor may be contrasted by an animals perception of it, for example. In humans and depending on the individual and the circumstances, defecation may occur daily, extensive hardening of the feces may cause prolonged interruption in the routine and is called constipation. Human fecal matter varies significantly in appearance, depending on diet, normally it is semisolid, with a mucus coating. The brown coloration comes from a combination of bile and bilirubin, in newborn babies, initially fecal matter is yellow-green after the meconium. This coloration comes from the presence of bile alone, throughout the life of an ordinary human, one may experience many types of feces
3.
Hemoglobin
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Hemoglobin in the blood carries oxygen from the respiratory organs to the rest of the body. There it releases the oxygen to permit aerobic respiration to provide energy to power the functions of the organism in the process called metabolism, in mammals, the protein makes up about 96% of the red blood cells dry content, and around 35% of the total content. Hemoglobin has a capacity of 1.34 mL O2 per gram. The mammalian hemoglobin molecule can bind up to four oxygen molecules, Hemoglobin is involved in the transport of other gases, It carries some of the bodys respiratory carbon dioxide as carbaminohemoglobin, in which CO2 is bound to the globin protein. The molecule also carries the important regulatory molecule nitric oxide bound to a globin protein thiol group, Hemoglobin is also found outside red blood cells and their progenitor lines. Other cells that contain hemoglobin include the A9 dopaminergic neurons in the substantia nigra, macrophages, alveolar cells, in these tissues, hemoglobin has a non-oxygen-carrying function as an antioxidant and a regulator of iron metabolism. Hemoglobin and hemoglobin-like molecules are found in many invertebrates, fungi. In these organisms, hemoglobins may carry oxygen, or they may act to transport and regulate other small molecules and ions such as carbon dioxide, nitric oxide, hydrogen sulfide and sulfide. In 1825 J. F. Engelhard discovered that the ratio of Fe to protein is identical in the hemoglobins of several species, from the known atomic mass of iron he calculated the molecular mass of hemoglobin to n ×16000, the first determination of a proteins molecular mass. This hasty conclusion drew a lot of ridicule at the time from scientists who could not believe that any molecule could be that big, gilbert Smithson Adair confirmed Engelhards results in 1925 by measuring the osmotic pressure of hemoglobin solutions. The oxygen-carrying protein hemoglobin was discovered by Hünefeld in 1840, hemoglobins reversible oxygenation was described a few years later by Felix Hoppe-Seyler. In 1959, Max Perutz determined the structure of myoglobin by X-ray crystallography. This work resulted in his sharing with John Kendrew the 1962 Nobel Prize in Chemistry, the role of hemoglobin in the blood was elucidated by French physiologist Claude Bernard. The name hemoglobin is derived from the heme and globin. Each heme group contains one iron atom, that can bind one oxygen molecule through ion-induced dipole forces, the most common type of hemoglobin in mammals contains four such subunits. Hemoglobin consists of subunits, and these proteins, in turn, are folded chains of a large number of different amino acids called polypeptides. The amino acid sequence of any polypeptide created by a cell is in turn determined by the stretches of DNA called genes, in all proteins, it is the amino acid sequence that determines the proteins chemical properties and function. There is more than one gene, in humans, hemoglobin A is coded for by the genes, HBA1, HBA2
4.
Tablet (pharmacy)
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A tablet is a pharmaceutical dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with or without suitable excipients and it comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose. The compressed tablet is the most popular form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, a tablet can be formulated to deliver an accurate dosage to a specific site, it is usually taken orally, but can be administered sublingually, buccally, rectally or intravaginally. The tablet is just one of the forms that an oral drug can take such as syrups, elixirs, suspensions. Medicinal tablets were made in the shape of a disk of whatever color their components determined. Tablets are often stamped with symbols, letters, and numbers, sizes of tablets to be swallowed range from a few millimeters to about a centimeter. Pills are thought to date back to around 1500 BC, earlier medical recipes, such as those from 4000 BC, were for liquid preparations rather than solids. The first references to pills were found on papyruses in ancient Egypt, medicinal ingredients, such as plant powders or spices, were mixed in and formed by hand to make little balls, or pills. In ancient Greece, such medicines were known as katapotia, and the Roman scholar Pliny, Pills have always been difficult to swallow and efforts long have been made to make them go down easier. In medieval times, people coated pills with slippery plant substances, another approach, used as recently as the 19th century, was to gild them in gold and silver, although this often meant that they would pass through the digestive tract with no effect. In the 1800s sugar-coating and gelatin-coating was invented, as were gelatin capsules, in 1843, the British painter and inventor William Brockedon was granted a patent for a machine capable of Shaping Pills, Lozenges and Black Lead by Pressure in Dies. The device was capable of compressing powder into a tablet without use of an adhesive, today, pills include tablets, capsules, and variants thereof like caplets—essentially anything with medication that can be digested, minus the liquid forms, colloquially falls into the pill category. A caplet is a smooth, coated, oval-shaped medicinal tablet in the shape of a capsule. Many caplets have a running down the middle so they may be split in half easier. An orally disintegrating tablet or orodispersible tablet, is a dosage form available for a limited range of over-the-counter. In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size, content uniformity ensures that the same API dose is delivered with each tablet. Some APIs may be tableted as pure substances, but this is rarely the case, normally, a pharmacologically inactive ingredient termed a binder is added to help hold the tablet together and give it strength
5.
Jmol
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Jmol is computer software for molecular modelling chemical structures in 3-dimensions. Jmol returns a 3D representation of a molecule that may be used as a teaching tool and it is written in the programming language Java, so it can run on the operating systems Windows, macOS, Linux, and Unix, if Java is installed. It is free and open-source software released under a GNU Lesser General Public License version 2.0, a standalone application and a software development kit exist that can be integrated into other Java applications, such as Bioclipse and Taverna. A popular feature is an applet that can be integrated into web pages to display molecules in a variety of ways, for example, molecules can be displayed as ball-and-stick models, space-filling models, ribbon diagrams, etc. Jmol supports a range of chemical file formats, including Protein Data Bank, Crystallographic Information File, MDL Molfile. There is also a JavaScript-only version, JSmol, that can be used on computers with no Java, the Jmol applet, among other abilities, offers an alternative to the Chime plug-in, which is no longer under active development. While Jmol has many features that Chime lacks, it does not claim to reproduce all Chime functions, most notably, Chime requires plug-in installation and Internet Explorer 6.0 or Firefox 2.0 on Microsoft Windows, or Netscape Communicator 4.8 on Mac OS9. Jmol requires Java installation and operates on a variety of platforms. For example, Jmol is fully functional in Mozilla Firefox, Internet Explorer, Opera, Google Chrome, fast and Scriptable Molecular Graphics in Web Browsers without Java3D
6.
N,N-Dimethyltryptamine
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N, N-Dimethyltryptamine is a powerful psychedelic compound of the tryptamine family. It is a analog of serotonin and melatonin and a functional analog of other psychedelic tryptamines such as 4-AcO-DMT, 5-MeO-DMT, 5-HO-DMT, psilocybin. Historically, it has been consumed by indigenous Amazonian cultures in the form of ayahuasca for divinatory and it was first synthesised in 1931, and in 1946, microbiologist Oswaldo Gonçalves de Lima discovered its natural presence in plants. In the 1960s, it was detected in mammalian organisms as well, DMT is known for its relatively short duration of action, intense effects and rapid onset. For that reason, DMT was known as a trip during the 1960s in the United States. DMT can be inhaled, injected, or orally ingested, and its effects depend on the dose, the effects last a short period of time,5 to 15 min. Longer effects can be achieved by oral ingestion, over 3 hours, DMT can produce psychedelic experiences involving euphoria and hallucinations. In most countries, DMT is illegal, the dependence potential of DMT and the risk of sustained psychological disturbance are minimal when used for religious ceremonies. DMT, like most psychedelics, is considered to be neither addictive, growth hormone blood levels rose equally in response to all doses of DMT, and melatonin levels were unaffected. Several scientific experimental studies have tried to measure subjective experiences of altered states of consciousness induced by drugs, here it is important to notice that in scientific studies measurements are conducted in laboratories under highly controlled and safe conditions. It appears that the set and setting have an influence, therefore if the drug is taken in different settings. In the 1990s, Strassman and his colleagues conducted a five year long DMT study at the University of New Mexico, the results provided insight about the quality of subjective psychedelic experiences. In this study received the DMT dosage intravenously via injection. Lower doses produced somaesthetic and emotional responses, but not hallucinogenic experiences, in contrary, higher doses researchers labeled as hallucinogenic that elicited intensely colored, rapidly moving display of visual images, formed, abstract or both. Comparing to other sensory modalities the most affected was visual domain, Strassman also stressed the importance of the context where drug has been taken. He claimed that DMT has no effects of itself, rather the context when. It appears that DMT can produce a hallucinogenic experience and it can induce a state or feeling to a person that she or he is able to communicate with other intelligent-life forms. High doses of DMT produce a state that involves sense of another intelligence that people sometimes describe as super-intelligent
7.
Injection (medicine)
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An injection follows a parenteral route of administration, that is, administration via a route other than through the digestive tract. Since the process involves a small puncture wound to the body. Rodents used for research are often administered intracerebral, intracerebroventricular, or intraportal injections as well, long-acting forms of subcutaneous/intramuscular injections are available for various drugs, and are called depot injections. Injections are among the most common health care procedures, with at least 16 billion administered in developing, 95% of injections are administered in curative care, 3% are for immunization, and the rest for other purposes, such as blood transfusions. In some instances the term injection is used synonymously with inoculation even by different workers in the same hospital and this should not cause confusion, the focus is on what is being injected/inoculated, not the terminology of the procedure. In an intramuscular injection, the medication is delivered directly into a muscle, many vaccines are administered intramuscularly, as are codeine, metoclopramide, and many other medications. Many drugs injected intramuscularly are absorbed into the muscle fairly quickly, injections to the buttocks are known to reach the bloodstream quickly due to the large amount of muscular tissue and corresponding blood supply. Such injection allows the compound to be released in a consistent way over a long period. Depot injections are usually either solid or oil-based, depot injections may be available as certain forms of a drug, such as decanoate salts or esters. Examples of depot injections include Depo Provera and haloperidol decanoate, prostate cancer patients receiving hormone therapy usually get depot injections as a treatment or therapy. Zoladex is an example of a medication delivered by depot for prostate cancer treatment or therapy, naltrexone may be administered in a monthly depot injection to control opiod abuse, in this case, the depot injection improves compliance by replacing daily pill administration. The advantages of using a long-acting depot injection include increased medication compliance due to reduction in the frequency of dosing, a significant disadvantage is that the drug is not immediately reversible, since it is slowly released. In psychiatric nursing, a short acting depot, zuclopenthixol acetate, the pharmaceutical injection type of infiltration involves loading a volume of tissue with the drug, filling the interstitial space. Local anesthetics are often infiltrated into the dermis and hypodermis, various animals, and some plants, have been injecting for various reasons long before humans began doing so in a process commonly called stinging. Some examples include, Snakes, wasps, scorpions, venom, to kill prey, some bees, venom, to defend themselves and their nests. Stinging nettles, venom, to try to avoid being eaten, stingrays, venom, defense mechanism when provoked. The pain of an injection may be lessened by prior application of ice or topical anesthetic, recent studies suggest that forced coughing during an injection stimulates a transient rise in blood pressure which inhibits the perception of pain. Sometimes, as with an amniocentesis, an anesthetic is given
8.
European Chemicals Agency
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ECHA is the driving force among regulatory authorities in implementing the EUs chemicals legislation. ECHA helps companies to comply with the legislation, advances the safe use of chemicals, provides information on chemicals and it is located in Helsinki, Finland. The Agency, headed by Executive Director Geert Dancet, started working on 1 June 2007, the REACH Regulation requires companies to provide information on the hazards, risks and safe use of chemical substances that they manufacture or import. Companies register this information with ECHA and it is freely available on their website. So far, thousands of the most hazardous and the most commonly used substances have been registered, the information is technical but gives detail on the impact of each chemical on people and the environment. This also gives European consumers the right to ask whether the goods they buy contain dangerous substances. The Classification, Labelling and Packaging Regulation introduces a globally harmonised system for classifying and labelling chemicals into the EU. This worldwide system makes it easier for workers and consumers to know the effects of chemicals, companies need to notify ECHA of the classification and labelling of their chemicals. So far, ECHA has received over 5 million notifications for more than 100000 substances, the information is freely available on their website. Consumers can check chemicals in the products they use, Biocidal products include, for example, insect repellents and disinfectants used in hospitals. The Biocidal Products Regulation ensures that there is information about these products so that consumers can use them safely. ECHA is responsible for implementing the regulation, the law on Prior Informed Consent sets guidelines for the export and import of hazardous chemicals. Through this mechanism, countries due to hazardous chemicals are informed in advance and have the possibility of rejecting their import. Substances that may have effects on human health and the environment are identified as Substances of Very High Concern 1. These are mainly substances which cause cancer, mutation or are toxic to reproduction as well as substances which persist in the body or the environment, other substances considered as SVHCs include, for example, endocrine disrupting chemicals. Companies manufacturing or importing articles containing these substances in a concentration above 0 and they are required to inform users about the presence of the substance and therefore how to use it safely. Consumers have the right to ask the retailer whether these substances are present in the products they buy, once a substance has been officially identified in the EU as being of very high concern, it will be added to a list. This list is available on ECHA’s website and shows consumers and industry which chemicals are identified as SVHCs, Substances placed on the Candidate List can then move to another list
9.
Pharmacokinetics
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Pharmacokinetics, sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as, pharmaceutical drugs, pesticides, food additives, cosmetic ingredients, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is eliminated from the body. Pharmacokinetics is the study of how an organism affects a drug, both together influence dosing, benefit, and adverse effects, as seen in PK/PD models. Pharmacokinetic properties of chemicals are affected by the route of administration and these may affect the absorption rate. Models have been developed to simplify conceptualization of the processes that take place in the interaction between an organism and a chemical substance. The various compartments that the model is divided into are commonly referred to as the ADME scheme, absorption - the process of a substance entering the blood circulation. Distribution - the dispersion or dissemination of substances throughout the fluids, metabolism – the recognition by the organism that a foreign substance is present and the irreversible transformation of parent compounds into daughter metabolites. Excretion - the removal of the substances from the body, in rare cases, some drugs irreversibly accumulate in body tissue. The two phases of metabolism and excretion can also be grouped together under the title elimination, the study of these distinct phases involves the use and manipulation of basic concepts in order to understand the process dynamics. All these concepts can be represented through mathematical formulas that have a graphical representation. The model outputs for a drug can be used in industry or in the application of pharmacokinetic concepts. Clinical pharmacokinetics provides many performance guidelines for effective and efficient use of drugs for human-health professionals, in practice, it is generally considered that steady state is reached when a time of 4 to 5 times the half-life for a drug after regular dosing is started. Noncompartmental methods estimate the exposure to a drug by estimating the area under the curve of a concentration-time graph, compartmental methods estimate the concentration-time graph using kinetic models. Noncompartmental methods are more versatile in that they do not assume any specific compartmental model. The final outcome of the transformations that a drug undergoes in an organism, a number of functional models have been developed in order to simplify the study of pharmacokinetics. These models are based on a consideration of an organism as a number of related compartments, the simplest idea is to think of an organism as only one homogenous compartment. However, these models do not always reflect the real situation within an organism
10.
Subcutaneous injection
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A subcutaneous injection is administered as a bolus into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the cutis. Subcutaneous injections are highly effective in administering vaccines and medications such as insulin, morphine, diacetylmorphine, subcutaneous, as opposed to intravenous, injection of recreational drugs is referred to as skin popping. Subcutaneous administration may be abbreviated as SC, SQ, sub-cu, sub-Q, SubQ, subcut is the preferred abbreviation for patient safety. Subcutaneous tissue has few blood vessels and so drugs injected here are for slow and it is slower than Intramuscular injections but still faster than intradermal injections. Sites include, The outer area of the upper arm, the abdomen, from the rib margin to the iliac crest and avoiding a 2-inch circle around the navel. This has the fastest rate of absorption among the sites, the front of the thigh, midway to the outer side,4 inches below the top of the thigh to 4 inches above the knee. This has a rate of absorption than the upper arm. The upper area of the buttock, just behind the hip bone and this has the slowest rate of absorption among the sites. A25 to 31 gauge thick, 3/8 to 1 long needle can be used, the size is determined by the amount of subcutaneous tissue present, which is based on patient build. The 3/8 and 5/8 needles are most commonly used, usually, no more than 1 mL of solution is given, compared to intradermal injections, where no more than 0.5 mL is usually given. Medication is administered slowly, about 10 seconds/milliliter, a person with insulin dependent diabetes mellitus typically injects insulin subcutaneously. The injection should be given under the skin, into the fat layer
11.
Excretion
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Excretion is the process by which metabolic wastes and other non-useful materials are eliminated from an organism. In vertebrates this is carried out by the lungs, kidneys. This is in contrast with secretion, where the substance may have specific tasks after leaving the cell, excretion is an essential process in all forms of life. For example, in urine is expelled through the urethra. In unicellular organisms, waste products are discharged directly through the surface of the cell, green plants produce carbon dioxide and water as respiratory products. In green plants, the carbon dioxide released during respiration gets utilized during photosynthesis, oxygen is a by product generated during photosynthesis, and exits through stomata, root cell walls, and other routes. Plants can get rid of water by transpiration and guttation. These latter processes do not need added energy, they act passively, however, during the pre-abscission phase, the metabolic levels of a leaf are high. Plants also excrete some waste substances into the soil around them, in animals, the main excretory products are carbon dioxide, ammonia, urea, uric acid, guanine and creatine. The liver and kidneys clear many substances from the blood, aquatic animals usually excrete ammonia directly into the external environment, as this compound has high solubility and there is ample water available for dilution. In terrestrial animals ammonia-like compounds are converted into other materials as there is less water in the environment. Birds excrete their nitrogenous wastes as uric acid in the form of a paste and this is metabolically more expensive, but allows more efficient water retention and it can be stored more easily in the egg. Many avian species, especially seabirds, can also excrete salt via specialized nasal salt glands, in insects, a system involving Malpighian tubules is utilized to excrete metabolic waste. Metabolic waste diffuses or is actively transported into the tubule, which transports the wastes to the intestines, the metabolic waste is then released from the body along with fecal matter. The excreted material may be called dejecta or ejecta, in pathology the word ejecta is more commonly used. UAlberta. ca, Animation of excretion Brian J Ford on leaf fall in Nature
