Erenumab
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Erenumab
Erenumab, sold under the brand name Aimovig, is a medication which targets the calcitonin gene-related peptide receptor (CGRPR) for the prevention of migraine. It is administered by subcutaneous injection. Erenumab, which was developed by Amgen and Novartis, was approved in May 2018, and was the first CGRPR antagonist to be approved by the U.S. Food and Drug Administration. In 2020, it was the 234th most commonly prescribed medication in the United States, with more than 1million prescriptions. Medical uses Erenumab is indicated for the prevention of migraine in adults. Side effects Common side effects are constipation, pruritus, muscle spasms, as well as mild and mostly transient reactions at the injection site. Interactions Erenumab was shown not to interact with ethinylestradiol, norgestimate or the migraine drug sumatriptan. It is expected to generally have a low potential for interactions because it is not metabolized by cytochrome P450 enzymes. Pharmacology Mech ...
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Migraine
Migraine (, ) is a common neurological disorder characterized by recurrent headaches. Typically, the associated headache affects one side of the head, is pulsating in nature, may be moderate to severe in intensity, and could last from a few hours to three days. Non-headache symptoms may include nausea, vomiting, and photophobia, sensitivity to light, hyperacusis, sound, or Osmophobia, smell. The pain is generally made worse by physical activity during an attack,as PDF
although regular physical exercise may prevent future attacks. Up to one-third of people affected have Aura (symptom), aura: typically, it is a short period of visual disturbance that signals that the headache will soon occur. Occasionally, aura can occur with little or no headache follow ...
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Calcitonin Gene-related Peptide Receptor
Calcitonin receptor-like (CALCRL), also known as the calcitonin receptor-like receptor (CRLR), is a human protein; it is a Receptor (biochemistry), receptor for calcitonin gene-related peptide. Function The protein encoded by the CALCRL gene is a G protein-coupled receptor related to the calcitonin receptor. CALCRL is linked to one of three single transmembrane domain receptor activity-modifying proteins (RAMPs) that are essential for functional activity. The association of CALCRL with different RAMP proteins produces different receptors: * with RAMP1: produces a CGRP receptor * with RAMP2: produces an adrenomedullin (AM) receptor, designated AM1 * with RAMP3: produces a dual CGRP/AM receptor designated AM2 These receptors are linked to the G protein Gs alpha subunit, Gs, which activates adenylate cyclase and activation results in the generation of intracellular cyclic adenosine monophosphate (cAMP). CGRP receptors are found throughout the body, suggesting that the protein may ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal 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 not onl ...
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National Institute Of Health And Care Excellence
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care in England that publishes guidelines in four areas: * the use of health technologies within England's National Health Service (NHS) and NHS Wales (such as the use of new and existing medicines, treatments and procedures) * clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions) * guidance for public sector workers on health promotion and ill-health avoidance * guidance for social care services and users. These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances. It serves both the English NHS and the Welsh NHS. It was set up as the National Institute for Clinical Excellence in 1999, and on 1 April 2005 joined with the Health Development Agency to become the new National Institute for Healt ...
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Scottish Medicines Consortium
Healthcare Improvement Scotland (HIS) is the national healthcare improvement organisation for Scotland. It is a public body which is part of the Scottish National Health Service, created in April 2011. History NHS Quality Improvement Scotland (NHS QIS) was established on 1 January 2003 as a special health board with a remit to improve the quality of healthcare in Scotland. Healthcare Improvement Scotland (HIS) was established by the Public Services Reform (Scotland) Act 2010, taking over the work of QIS and the regulatory functions, in regard to independent healthcare provision, previously conducted by the Care Commission, now renamed the Care Inspectorate. The first chair of HIS, serving from 2010 to 2018, was Dame Denise Coia. The function of this body is to implement the healthcare priorities of the Scottish Government, in particular the Healthcare Quality Strategy of NHS Scotland. Units Healthcare Improvement Scotland incorporates several organisations: * Healthcare Envi ...
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The New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid digital subscribers. It also is a producer of popular podcasts such as '' The Daily''. Founded in 1851 by Henry Jarvis Raymond and George Jones, it was initially published by Raymond, Jones & Company. The ''Times'' has won 132 Pulitzer Prizes, the most of any newspaper, and has long been regarded as a national " newspaper of record". For print it is ranked 18th in the world by circulation and 3rd in the U.S. The paper is owned by the New York Times Company, which is publicly traded. It has been governed by the Sulzberger family since 1896, through a dual-class share structure after its shares became publicly traded. A. G. Sulzberger, the paper's publisher and the company's chairman, is the fifth generation of the family to head the pa ...
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Placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general, placebos can affect how patients perceive their condition and encourage the body's chemical processes for relieving pain and a few other symptoms, but have no impact on the disease itself. Improvements that patients experience after being treated with a placebo can also be due to unrelated factors, such as regression to the mean (a statistical effect where an unusually high or low measurement is likely to be followed by a less extreme one). The use of placebos in clinical medicine raises ethical concerns, especially if they are disguised as an active treatment, as this introduces dishonesty into the doctor–patient relationship and bypasses informed consent. While it was once assumed that this deception was necessary for placebos to have ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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Phase III Clinical Trials
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over severa ...
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Elimination Half-life
Biological half-life (also known as elimination half-life, pharmacologic half-life) is the time taken for concentration of a biological substance (such as a medication) to decrease from its maximum concentration ( Cmax) to half of Cmax in the blood plasma, and is denoted by the abbreviation t_. This is used to measure the removal of things such as metabolites, drugs, and signalling molecules from the body. Typically, the biological half-life refers to the body's natural cleansing through the function of the liver and through the excretion of the measured substance through the kidneys and intestines. This concept is used when the rate of removal is roughly exponential. In a medical context, half-life explicitly describes the time it takes for the blood plasma concentration of a substance to halve (''plasma half-life'') its steady-state when circulating in the full blood of an organism. This measurement is useful in medicine, pharmacology and pharmacokinetics because it helps det ...
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Amino Acid
Amino acids are organic compounds that contain both amino and carboxylic acid functional groups. Although hundreds of amino acids exist in nature, by far the most important are the alpha-amino acids, which comprise proteins. Only 22 alpha amino acids appear in the genetic code. Amino acids can be classified according to the locations of the core structural functional groups, as Alpha and beta carbon, alpha- , beta- , gamma- or delta- amino acids; other categories relate to Chemical polarity, polarity, ionization, and side chain group type (aliphatic, Open-chain compound, acyclic, aromatic, containing hydroxyl or sulfur, etc.). In the form of proteins, amino acid '' residues'' form the second-largest component (water being the largest) of human muscles and other tissues. Beyond their role as residues in proteins, amino acids participate in a number of processes such as neurotransmitter transport and biosynthesis. It is thought that they played a key role in enabling life ...
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Peptide
Peptides (, ) are short chains of amino acids linked by peptide bonds. Long chains of amino acids are called proteins. Chains of fewer than twenty amino acids are called oligopeptides, and include dipeptides, tripeptides, and tetrapeptides. A polypeptide is a longer, continuous, unbranched peptide chain. Hence, peptides fall under the broad chemical classes of biological polymers and oligomers, alongside nucleic acids, oligosaccharides, polysaccharides, and others. A polypeptide that contains more than approximately 50 amino acids is known as a protein. Proteins consist of one or more polypeptides arranged in a biologically functional way, often bound to ligands such as coenzymes and cofactors, or to another protein or other macromolecule such as DNA or RNA, or to complex macromolecular assemblies. Amino acids that have been incorporated into peptides are termed residues. A water molecule is released during formation of each amide bond.. All peptides except cyclic pep ...
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