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Endoxifen
Endoxifen, also known as 4-hydroxy-''N''-desmethyltamoxifen, is a nonsteroidal selective estrogen receptor modulator (SERM) of the triphenylethylene group as well as a protein kinase C (PKC) inhibitor. It is under development for the treatment of estrogen receptor-positive breast cancer and for the treatment of mania in bipolar disorder. It is taken by mouth. Endoxifen is an active metabolite of tamoxifen and has been found to be effective in patients that have failed previous hormonal therapies (tamoxifen, aromatase inhibitors, and fulvestrant). The prodrug tamoxifen is metabolized by the CYP2D6 enzyme to produce endoxifen and afimoxifene (4-hydroxytamoxifen). Currently, endoxifen is approved by Drugs Controller General of India for the acute treatment of manic episode with or without mixed features of Bipolar I disorder. It is manufactured and sold by Intas Pharmaceuticals under the brand name Zonalta. Medical uses Bipolar disorder Endoxifen is used to treat manic or m ...
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Tamoxifen
Tamoxifen, sold under the brand name Nolvadex among others, is a selective estrogen receptor modulator used to prevent breast cancer in women and treat breast cancer in women and men. It is also being studied for other types of cancer. It has been used for Albright syndrome. Tamoxifen is typically taken daily by mouth for five years for breast cancer. Serious side effects include a small increased risk of uterine cancer, stroke, vision problems, and pulmonary embolism. Common side effects include irregular periods, weight loss, and hot flashes. It may cause harm to the baby if taken during pregnancy or breastfeeding. It is a selective estrogen-receptor modulator (SERM) and works by decreasing the growth of breast cancer cells. It is a member of the triphenylethylene group of compounds. Tamoxifen was initially made in 1962, by chemist Dora Richardson. It is on the World Health Organization's List of Essential Medicines. Tamoxifen is available as a generic medication. ...
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Oral Administration
Oral administration is a route of administration where a substance is taken through the mouth. Per os abbreviated to P.O. is sometimes used as a direction for medication to be taken orally. Many medications are taken orally because they are intended to have a systemic effect, reaching different parts of the body via the bloodstream, for example. Oral administration can be easier and less painful than other routes, such as injection. However, the onset of action is relatively low, and the effectiveness is reduced if it is not absorbed properly in the digestive system, or if it is broken down by digestive enzymes before it can reach the bloodstream. Some medications may cause gastrointestinal side effects, such as nausea or vomiting, when taken orally. Oral administration can also only be applied to conscious patients, and patients willing and able to swallow. Terminology ''Per os'' (; ''P.O.'') is an adverbial phrase meaning literally from Latin "through the mouth" or "by mouth ...
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Cancer Research (journal)
''Cancer Research'' is a biweekly peer-reviewed medical journal published by the American Association for Cancer Research. It covers research on all aspects of cancer and cancer-related biomedical sciences and was established in 1941. The editor-in-chief is Chi Van Dang. The journal was established in 1916 as the ''Journal of Cancer Research'', was renamed ''American Journal of Cancer'' in 1931, and obtained its current name in 1941. Abstracting and indexing The journal is abstracted and indexed in: According to the ''Journal Citation Reports'', the journal has a 2020 impact factor The impact factor (IF) or journal impact factor (JIF) of an academic journal is a scientometric index calculated by Clarivate that reflects the yearly mean number of citations of articles published in the last two years in a given journal, as ... of 12.701. References External links * {{Official website, http://cancerres.aacrjournals.org Oncology journals Publications established in 1916 ...
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Royal Society Of Chemistry
The Royal Society of Chemistry (RSC) is a learned society (professional association) in the United Kingdom with the goal of "advancing the chemistry, chemical sciences". It was formed in 1980 from the amalgamation of the Chemical Society, the Royal Institute of Chemistry, the Faraday Society, and the Society for Analytical Chemistry with a new Royal Charter and the dual role of learned society and professional body. At its inception, the Society had a combined membership of 34,000 in the UK and a further 8,000 abroad. The headquarters of the Society are at Burlington House, Piccadilly, London. It also has offices in Thomas Graham House in Cambridge (named after Thomas Graham (chemist), Thomas Graham, the first president of the Chemical Society) where ''RSC Publishing'' is based. The Society has offices in the United States, on the campuses of The University of Pennsylvania and Drexel University, at the University City Science Center in Philadelphia, Pennsylvania, in both Beijing a ...
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India
India, officially the Republic of India ( Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the south, the Arabian Sea on the southwest, and the Bay of Bengal on the southeast, it shares land borders with Pakistan to the west; China, Nepal, and Bhutan to the north; and Bangladesh and Myanmar to the east. In the Indian Ocean, India is in the vicinity of Sri Lanka and the Maldives; its Andaman and Nicobar Islands share a maritime border with Thailand, Myanmar, and Indonesia. Modern humans arrived on the Indian subcontinent from Africa no later than 55,000 years ago., "Y-Chromosome and Mt-DNA data support the colonization of South Asia by modern humans originating in Africa. ... Coalescence dates for most non-European populations average to between 73–55 ka.", "Modern human beings—''Homo sapiens''—originated in Africa. Th ...
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Bipolar I Disorder
Bipolar I disorder (BD-I; pronounced "type one bipolar disorder") is a type of bipolar spectrum disorder characterized by the occurrence of at least one manic episode, with or without mixed or psychotic features. Most people also, at other times, have one or more depressive episodes, and all experience a hypomanic stage before progressing to full mania. It is a type of bipolar disorder and conforms to the classic concept of manic-depressive illness, which can include psychosis during mood episodes. Diagnosis The essential feature of bipolar I disorder is a clinical course characterized by the occurrence of one or more manic episodes or mixed episodes. Often, individuals have had one or more major depressive episodes. One episode of mania is sufficient to make the diagnosis of bipolar disorder; the person may or may not have a history of major depressive disorder. Episodes of substance-induced mood disorder due to the direct effects of a medication, or other somatic treat ...
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Mixed Episode
A mixed affective state, formerly known as a mixed-manic or mixed episode, has been defined as a state wherein features unique to both depression and mania—such as episodes of despair, doubt, anguish, rage or homicidal ideation, suicidal ideation, splitting, racing thoughts, sensory overload, pressure of activity, and heightened irritability—occur either simultaneously or in very short succession. Previously, the diagnostic criteria for both a manic and depressive episode had to be met in a consistent and sustained fashion, with symptoms enduring for at least a week (or any duration if psychiatric hospitalization was required), thereby restricting the official acknowledgement of mixed affective states to only a minority of patients with bipolar I disorder. In current '' DSM-5'' nomenclature, however, a "mixed episode" no longer stands as an episode of illness unto itself; rather, the symptomology specifier "with mixed features" can be applied to any major affective episo ...
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Manic Episode
Mania, also known as manic syndrome, is a mental and behavioral disorder defined as a state of abnormally elevated arousal, affect, and energy level, or "a state of heightened overall activation with enhanced affective expression together with lability of affect." During a manic episode, an individual will experience rapidly changing emotions and moods, highly influenced by surrounding stimuli. Although mania is often conceived as a "mirror image" to depression, the heightened mood can be either euphoric or dysphoric. As the mania intensifies, irritability can be more pronounced and result in anxiety or anger. The symptoms of mania include elevated mood (either euphoric or irritable), flight of ideas and pressure of speech, increased energy, decreased need and desire for sleep, and hyperactivity. They are most plainly evident in fully developed hypomanic states. However, in full-blown mania, they undergo progressively severe exacerbations and become more and more obscured by ...
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Intas Pharmaceuticals
Intas Pharmaceuticals Limited is an Indian pharmaceutical company headquartered in Ahmedabad, Gujarat. History The company was founded by a Jain pharmacist Hasmukh Chudgar in 1977 and was incorporated in 1985. In 2013, ChrysCapital acquired 16.14% stake in the company, and in 2015, ChrysCapital subsequently sold 10.13% to Singapore-based Temasek Holdings and in 2017, it further diluted 3.01% stake to Capital International. Though, by May 2020, ChrysCapital bought back Capital International's stake. Currently, the Chudgar family, owns 83.85% stake in the company, with 10.13% being held by Temasek Holdings, and 6.02% by ChrysCapital. As of March 2021, the company is operating 19 manufacturing facilities globally - 13 in India, 5 in the UK, and 1 in Mexico. The company has set up a new manufacturing facility in PHARMEZ ( Bavla, near Ahmedabad) with capacity to manufacture and export more than 1 billion solid dosages and 5 million injectables. Divisions Biologics Unit (form ...
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Central Drugs Standard Control Organisation
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the National Medical Products Administration (NMPA) of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO). Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pre-li ...
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Drugs Controller General Of India
Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. Drugs Controller General of India, comes under the Ministry of Health & Family Welfare. DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India. Function DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India. * Preparation and maintenance of national reference standard. * To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. * Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions * Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules ...
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Afimoxifene
Afimoxifene, also known as 4-hydroxytamoxifen (4-OHT) and by its tentative brand name TamoGel, is a selective estrogen receptor modulator (SERM) of the triphenylethylene group and an active metabolite of tamoxifen. The drug is under development under the tentative brand name TamoGel as a topical gel for the treatment of hyperplasia of the breast. It has completed a phase II clinical trial for cyclical mastalgia, but further studies are required before afimoxifene can be approved for this indication and marketed. Afimoxifene is a SERM and hence acts as a tissue-selective agonist–antagonist of the estrogen receptors ERα and ERβ with mixed estrogenic and antiestrogenic activity depending on the tissue. It is also an agonist of the G protein-coupled estrogen receptor (GPER) with relatively low affinity (100–1,000 nM, relative to 3–6 nM for estradiol Estradiol (E2), also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone ...
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