Drug developmentDrug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.
Food and Drug AdministrationThe United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Approved drugAn approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise. In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition.
Drug designDrug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the biomolecular target with which they interact and therefore will bind to it.
Preclinical developmentIn drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals. The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics.
New Drug ApplicationThe Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.
Invasive speciesAn invasive or alien species is an introduced species to an environment that becomes overpopulated and harms its new environment. Invasive species adversely affect habitats and bioregions, causing ecological, environmental, and/or economic damage. The term can also be used for native species that become harmful to their native environment after human alterations to its food web - for example, the purple sea urchin (Strongylocentrotus purpuratus) which has decimated kelp forests along the northern California coast due to overharvesting of its natural predator, the California sea otter (Enhydra lutris).
Model organismA model organism (often shortened to model) is a non-human species that is extensively studied to understand particular biological phenomena, with the expectation that discoveries made in the model organism will provide insight into the workings of other organisms. Model organisms are widely used to research human disease when human experimentation would be unfeasible or unethical. This strategy is made possible by the common descent of all living organisms, and the conservation of metabolic and developmental pathways and genetic material over the course of evolution.
Introduced speciesAn introduced species, alien species, exotic species, adventive species, immigrant species, foreign species, non-indigenous species, or non-native species is a species living outside its native distributional range, but which has arrived there by human activity, directly or indirectly, and either deliberately or accidentally. Non-native species can have various effects on the local ecosystem. Introduced species that become established and spread beyond the place of introduction are considered naturalized.
Animal disease modelAn animal model (short for animal disease model) is a living, non-human, often genetic-engineered animal used during the research and investigation of human disease, for the purpose of better understanding the disease process without the risk of harming a human. Although biological activity in an animal model does not ensure an effect in humans, many drugs, treatments and cures for human diseases are developed in part with the guidance of animal models.
Orphan drugAn orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country.
Keystone speciesA keystone species is a species that has a disproportionately large effect on its natural environment relative to its abundance, a concept introduced in 1969 by the zoologist Robert T. Paine. Keystone species play a critical role in maintaining the structure of an ecological community, affecting many other organisms in an ecosystem and helping to determine the types and numbers of various other species in the community. Without keystone species, the ecosystem would be dramatically different or cease to exist altogether.
Animal testingAnimal 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.
FlyFlies are insects of the order Diptera, the name being derived from the Greek δι- di- "two", and πτερόν pteron "wing". Insects of this order use only a single pair of wings to fly, the hindwings having evolved into advanced mechanosensory organs known as halteres, which act as high-speed sensors of rotational movement and allow dipterans to perform advanced aerobatics. Diptera is a large order containing an estimated 1,000,000 species including horse-flies, crane flies, hoverflies and others, although only about 125,000 species have been described.
Ceratitis capitataCeratitis capitata, commonly known as the Mediterranean fruit fly or medfly, is a yellow-and-brown fly native to sub-Saharan Africa. It has no near relatives in the Western Hemisphere and is considered to be one of the most destructive fruit pests in the world. There have been occasional medfly infestations in California, Florida, and Texas that require extensive eradication efforts to prevent the fly from establishing itself in the United States. C.
MedicationA medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in many ways.
TephritidaeThe Tephritidae are one of two fly families referred to as fruit flies, the other family being the Drosophilidae. The family Tephritidae does not include the biological model organisms of the genus Drosophila (in the family Drosophilidae), which is often called the "common fruit fly". Nearly 5,000 described species of tephritid fruit fly are categorized in almost 500 genera of the Tephritidae. Description, recategorization, and genetic analyses are constantly changing the taxonomy of this family.
MouseA mouse (: mice) is a small rodent. Characteristically, mice are known to have a pointed snout, small rounded ears, a body-length scaly tail, and a high breeding rate. The best known mouse species is the common house mouse (Mus musculus). Mice are also popular as pets. In some places, certain kinds of field mice are locally common. They are known to invade homes for food and shelter. Mice are typically distinguished from rats by their size. Generally, when a muroid rodent is discovered, its common name includes the term mouse if it is smaller, or rat if it is larger.
DrugA drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via inhalation, injection, smoking, ingestion, absorption via a patch on the skin, suppository, or dissolution under the tongue. In pharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect.
Clinical trialClinical 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.
