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A drug is a substance which may have medicinal, intoxicating, performance enhancing or other effects when taken or put into a human body or the body of another animal and is not considered a food or exclusively a food. What is considered a drug rather than a food varies between cultures, and distinctions between drugs and foods and between kinds of drug are enshrined in laws which vary between jurisdictions and aim to restrict or prevent drug use. Even within a jurisdiction, however, the status of a substance may be uncertain or contested with respect to both whether it is a drug and how it should be classified if at all. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage. In pharmacology, a drug is "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being." Drugs may be prescribed for a limited duration, or on a regular basis for chronic disorders. Recreational drugs are chemical substances that affect the central nervous system, such as opioids or hallucinogens. They may be used for perceived beneficial
insulin is a hormone that is synthesized in the body. Etymology Drug is thought to originate from Old French "drogue". as when ingested they affect the functioning of both mind and body and some substances normally considered drugs such as DMT (Dimethyltryptamine) are actually produced by the human body in trace amounts. personality. wines.effects on perception. consciousness. Drugs are usually distinguished from endogenous biochemicals by being introduced from outside the organism. such as beers. blur the line between food and recreational drugs. Many natural substances. For example. it is called a drug. and behavior. Some drugs can cause addiction and/or habituation. possibly deriving later into "droge-vate" from Middle Dutch meaning "dry barrels". . but if it is introduced into the body from outside. it is called a hormone when it is synthesized by the pancreas inside the body. referring to medicinal plants preserved in them. and psychoactive mushrooms.
Dispensing of medication is often regulated by governments into three categories—over-the-counter (OTC) medications. BTC medicines are called pharmacy medicines which can only be sold in registered pharmacies. usually a physician. or may be used as preventive medicine that has future benefits but does not treat any existing or pre-existing diseases or symptoms. behind-the-counter (BTC).Medication Nexium pills 40 mg A medication or medicine is a drug taken to cure and/or ameliorate any symptoms of an illness or medical condition. by or under the supervision of a pharmacist. . which are dispensed by a pharmacist without needing a doctor's prescription. which must be prescribed by a licensed medical professional. and prescription only medicines (POM). which are available in pharmacies and supermarkets without special restrictions. In the United Kingdom.
 The range of medicines available without a prescription varies from country to country. . in cultivation. Drugs that are considered to have spiritual or religious use are called entheogens. Those that are not patented (or with expired patents) are called generic drugs since they can be produced by other companies without restrictions or licenses from the patent holder. Peyote has been used in ritual contexts for thousands of years. The spiritual and religious use of drugs has been occurring since the dawn of our species. Some religions are based completely on the use of certain drugs.These medications are designated by the letter P on the label. Spiritual and religious use A group of peyotes. Medications are typically produced by pharmaceutical companies and are often patented to give the developer exclusive rights to produce them.
thought. also commonly referred to as "smart drugs". Self-improvement Nootropics. often by professional athletes. . Recreational drug use The cigarette is the common pharmaceutical form of tobacco – one of the world’s best selling drugs. drugs such as steroids improve human physical capabilities and are sometimes used (legally or not) for this purpose. Nootropics are used to improve memory. Similarly. learning. being either psychedelics or deliriants. They are also commonly used to regain brain function lost during aging. mood. Parkinson's disease. and many other things. concentration.Entheogens are mostly hallucinogens. Some nootropics are now beginning to be used to treat certain diseases such as attention-deficit hyperactivity disorder. but some are also stimulants and sedatives. are drugs that are claimed to improve human cognitive abilities. and Alzheimer's disease.
Because of the legal status of many drugs. recreational drug use is controversial. a brew with psychoactive properties used for shamanistic purposes in the Peruvian Amazon Recreational drugs use is the use of psychoactive substances to have fun. and at the most have an age restriction on using and/or purchasing them. with many governments not recognising spiritual or other perceived uses for drugs and classing them under illegal recreational use. National laws prohibit the use of many different recreational drugs and medicinal drugs that have the potential for recreational use are heavily regulated. widely culturally accepted. betel nut. for the experience. . and caffeine products in the west. and in other localised areas of the world drugs such as Khat are common. Ayahuasca. tobacco. Many other recreational drugs on the other hand are legal. These include alcohol. or to enhance an already positive experience.Cannabis is another commonly used recreational drug.
Many drugs can be administered in a variety of ways rather than just one. Sublingually. Orally. Vaginally as a suppository. that is absorbed by the rectum or colon. Rectally as a suppository. Inhaled. Bolus) is the administration of a medication.Administering drugs Drugs. or snorted into the nose. can be administered in a number of ways. Insufflation. as a liquid or solid. (breathed into the lungs). intraperitoneal. usually as a cream or ointment. intraosseous. primarily to treat vaginal infections. diffusing into the blood through tissues under the tongue. (This includes smoking a substance) Injected as a solution. intrathecal or subcutaneous injection. A drug administered in this manner may be given to act locally or systemically. Topically. that is absorbed through the intestines. . intravenous. by intramuscular. as an aerosol or dry powder. both medicinal and recreational. drug or other compound that is given to raise its concentration in blood to an effective level. suspension or emulsion either: intramuscular. The administration can be given intravenously.
New chemical entity development Regulation of therapeutic goods in the United States Prescription drugs Over-the-counter drugs .Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research (microorganisms/animals) and clinical trials (on humans) and may include the step of obtaining regulatory approval to market the drug.
Broadly. also known as new molecular entities or NMEs) are compounds which emerge from the process of drug discovery. it can be manufactured on the kilogram and then on the ton scale. The process by which the chemical is made will be optimized so that from being made at the bench on a milligram scale by a medicinal chemist. the process of drug development can be divided into pre-clinical and clinical work. A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time an NCE is used in a human clinical trial ("first-inman" [FIM] or First Human Dose [FHD]). It is the function of drug development to assess all of these parameters prior to human clinical trials. however. aeresol. toxicity. little will be known about the safety. These will have promising activity against a particular biological target thought to be important in disease. intramuscular injectable. It will be further examined for its suitability to be made into capsules. drug development is required to establish the physicochemical properties of the NCE: its chemical makeup. pharmacokinetics and metabolism of this NCE in humans. tablets. Pre-clinical New chemical entities (NCEs. stability. In addition. solubility. subcuteneous .
as an Investigational New Drug application or IND. the skin if the new drug is to be delivered through the skin).g. these tests can be made using in vitro methods (e. Manufacturing and Control (CMC). liver and digestive system). Together these processes are known in preclinical development as Chemistry. While. If the IND is approved. or intravenous formulations. brain. to the FDA). Many aspects of drug development are focused on satisfying the regulatory requirements of drug licensing authorities. kidney.g. as well as effects on other parts of the body that might be affected by the drug (e. increasingly. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in man. It is a legal requirement that an assessment of major organ toxicity be performed (effects on the heart and lungs. .injectable. development moves to the clinical phase. and is submitted to regulatory authorities (in the US. as well as information on CMC. since it is only in an intact organism that the complex interplay of metabolism and drug exposure on toxicity can be examined. many tests can only be made by using experimental animals. The information gathered from this pre-clinical testing. with isolated cells).
this process is called a New Drug Application or NDA. determine safety and dosing. however. as well as effects on systems not previously monitored (fertility. Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of sick patients.). usually in healthy volunteers. fail during drug development. Phase III trials are large. In addition to the tests required to move a novel drug into the clinic for the first time it is also important to ensure that long-term or chronic toxicities are determined. Most NCEs.Clinical phase Clinical trials involves three steps: Phase I trials. The process of drug development does not stop once an NCE begins human clinical trials. then it can be submitted for marketing approval in the various countries where it will be sold. The compound will also be tested for its capability to cause cancer (carcinogenicity testing). either because they . If a compound emerges from these tests with an acceptable toxicity and safety profile. In the US. etc. reproduction. immune system. pivotal trials to determine safety and efficacy in sufficiently large numbers of patients. and it can further be demonstrated to have the desired effect in clinical trials.
or because they simply do not work in clinical trials. provides both capitalized and out-of-pocket costs .the numbers also vary greatly at the high end.is complex and controversial. The controversy is not only between "high" and "low" -. but also include "capital costs". which are included to take into account the long time period (often at least ten years) during which the out-of-pocket costs are expended. A study published by Steve Paul et al. released by them voluntarily.e. Another element of complexity is that all estimates are based on confidential information owned by drug companies. as drug companies use them to justify the prices of their drugs and various advocates for lower drug prices have challenged them. The numbers are controversial. a drug that is a new chemical entity) to market . in 2010 in Nature Reviews: Drug Discovery compares many of the studies. There is currently no way to validate these numbers.from discovery through clinical trials to approval . One element of the complexity is that the much-publicized final numbers often do not include just the simple out-of-pocket expenses. Cost The full cost of bringing a new drug (i. additionally it is often not stated whether a given figure includes the capitalized cost or comprises only out-of-pocket expenses.have some unacceptable toxicity.
including an author from the US Federal Trade Commission. A study published in 2006 estimates that costs vary from around $500 million to $2 billion depending on the therapy or the developing firm.5 percent of drugs that start phase I trials are eventually approved for marketing.000 to 10.  A study conducted by the Tufts Center for the Study of Drug Development covering the 1980s and 1990s found that only 21. capitalized cost of approximately $800 million to bring one of the drugs from the study to market. about ten of these will qualify for tests on humans. this $800 million dollar figure includes opportunity costs of $400 million.8B. Typically. with outof-pocket costs of ~$870M. The high failure rates associated with pharmaceutical . mice and other test animals. A study published in 2010 in the journal Health Economics. The authors offer their own estimate of the capitalized cost as being ~$1. but came up with a higher estimate of ~$1. in 2003. On average about 250 of these will show sufficient promise for further evaluation using laboratory tests. was critical of the methods used by diMasi et al. Also.for each. report an average pre-tax.2 billion. Studies published by diMasi et al.000 chemical compounds. and lays out the assumptions each makes: see Supplemental Box 2. Success rate Candidates for a new drug to treat a disease might theoretically include from 5.
and examples of major national initiatives are Top Institute Pharma in the Netherlands and Biopeople in Denmark. the FDA created the ―Critical Path Initiative‖ (CPI) project to guide the new drug development process. In 2004. The worlds largest such initiative is the Innovative Medicines Initiative (IMI). In many cases. Well designed dose-finding studies and comparisons against both a placebo and a gold-standard treatment arm play a major role in achieving reliable data. Careful decision making during drug development is essential to avoid costly failures. intelligent programme and clinical trial design can prevent false negative results.development are referred to as the "attrition rate" problem. . Novel initiatives to boost drug development Novel initiaives include partnering between governmental organisations and industry.