PRO 2000
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PRO 2000
PRO 2000 is an experimental vaginal microbicide which has been proposed as a preventive medicine for reducing the risk of contracting HIV. It has never been recommended as an effective medicine to be used for any purpose. Some clinical trials have shown that under some conditions it may provide some protection against HIV. History Endo Pharmaceuticals manufactures the drug. Efficacy Animal testing studies done on macaques have shown that PRO 2000 is effective in preventing the transmission of HIV. Other studies have given supportive evidence that the product is safe in humans and would be an appropriate candidate for testing. A phase III clinical trial of 9385 women in sub-Saharan Africa Sub-Saharan Africa is, geographically, the area and regions of the continent of Africa that lies south of the Sahara. These include West Africa, East Africa, Central Africa, and Southern Africa. Geopolitically, in addition to the List of sov ... showed that PRO 2000 was not effective in ...
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Vaginal Microbicide
A vaginal microbicide is a microbicide for vaginal use. Most commonly such a product would be a topical gel or cream inserted into the vagina so that it may treat some infection in the vagina, such as types of vaginitis. Along with rectal microbicides, vaginal microbicides are currently the subject of medical research on microbicides for sexually transmitted diseases to determine the circumstances under which and the extent to which they provide protection against infection. Researchers are trying to develop a product which would act as protection against the contraction of a sexually transmitted infection during vaginal sexual intercourse. Vaginal microbicides for sexually transmitted diseases Scientists are trying to develop effective microbicides to reduce the risk of contracting a sexually transmitted infection, and in particular, to reduce the risk of contracting HIV. Target market Researchers have investigated who has interest in using a vaginal microbicide. Condoms are h ...
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Preventive Medicine
Preventive healthcare, or prophylaxis, consists of measures taken for the purposes of disease prevention.Hugh R. Leavell and E. Gurney Clark as "the science and art of preventing disease, prolonging life, and promoting physical and mental health and efficiency. Leavell, H. R., & Clark, E. G. (1979). Preventive Medicine for the Doctor in his Community (3rd ed.). Huntington, NY: Robert E. Krieger Publishing Company. Disease and disability are affected by environmental factors, genetic predisposition, disease agents, and lifestyle choices, and are dynamic processes which begin before individuals realize they are affected. Disease prevention relies on anticipatory actions that can be categorized as primal, primary, secondary, and tertiary prevention. Each year, millions of people die of preventable deaths. A 2004 study showed that about half of all deaths in the United States in 2000 were due to preventable behaviors and exposures. Leading causes included cardiovascular disease, ...
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Clinical Trials
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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Endo Pharmaceuticals
Endo International plc is an American Irish-domiciled generics and specialty branded pharmaceutical company that generated over 93% of its 2017 sales from the U.S. healthcare system. While Endo's management, operations, and customers are almost exclusively U.S.–based, in 2013 Endo executed a corporate tax inversion to Ireland to avoid U.S. corporate taxes on their U.S. drug sales, and to avail of Ireland's corporate tax system. History and Acquisitions Endo was created as a result of a management buyout from DuPont Merck in 1997 led by Carol Ammon. In 2009, Endo bought Indevus Pharmaceuticals to diversify into endocrinology and oncology. The company entered the male hypogonadism market later in 2010 with Fortesta 2% gel. In November 2013, Endo agreed to purchase Paladin Labs Inc for about $1.6 billion to gain access to the Canadian market as well as expand into emerging markets. Endo used the 2013 acquisition of Paladin Labs, and Canadian tax laws, to execute a corpora ...
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Animal Testing
Animal testing, also known as animal experimentation, animal research, and ''in vivo'' testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. 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 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, including cosmetics testing. In edu ...
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Macaques
The macaques () constitute a genus (''Macaca'') of sociality, gregarious Old World monkeys of the subfamily Cercopithecinae. The 23 species of macaques inhabit species distribution, ranges throughout Asia, North Africa, and (in barbary macaques in Gibraltar, one instance) Gibraltar. Macaques are principally frugivore, frugivorous (preferring fruit), although their diet also includes seeds, leaves, flowers, and tree bark. Some species, such as the crab-eating macaque, subsist on a diet of invertebrates and occasionally small vertebrates. On average, southern pig-tailed macaques in Malaysia eat about 70 large rats each per year. All macaque social groups are matriarchy, matriarchal, arranged around dominant females. Macaques are found in a variety of habitats throughout the Asian continent and are highly adaptation, adaptable. Certain species have learned to synanthrope, live with humans and have become invasive in some human settlement, human-settled built environment, environment ...
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Phase III Clinical Trial
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 sever ...
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Sub-Saharan Africa
Sub-Saharan Africa is, geographically, the area and regions of the continent of Africa that lies south of the Sahara. These include West Africa, East Africa, Central Africa, and Southern Africa. Geopolitically, in addition to the List of sovereign states and dependent territories in Africa, African countries and territories that are situated fully in that specified region, the term may also include polities that only have part of their territory located in that region, per the definition of the United Nations (UN). This is considered a non-standardized geographical region with the number of countries included varying from 46 to 48 depending on the organization describing the region (e.g. UN, WHO, World Bank, etc.). The Regions of the African Union, African Union uses a different regional breakdown, recognizing all 55 member states on the continent - grouping them into 5 distinct and standard regions. The term serves as a grouping counterpart to North Africa, which is instead ...
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