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Drug development, the Glossary

Index Drug development

Drug 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.[1]

Table of Contents

  1. 62 relations: Amazon (company), Antiviral drug, Breakthrough therapy, Capital expenditure, Capsule (pharmacy), Cardiology, Cash flow, Churn rate, Clinical trial, Comparables, COVID Moonshot, Decision tree, Drug design, Drug discovery, Drug repositioning, Europe, the Middle East and Africa, Food and Drug Administration, Forbes, Formulation, Generic drug, Google, Hewlett Packard Enterprise, IBM, In vitro, Innovative Medicines Initiative, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Intravenous therapy, Investigational New Drug, List of pharmaceutical companies, Median, Medication, Medicinal chemistry, Metabolism, Microsoft, Ministry of Health, Labour and Welfare, NASA, National Science Foundation, New chemical entity, New Drug Application, Open science, Oral medicine, Patent, Pharmaceutical engineering, Pharmaceutical industry, Pharmaceutical manufacturing, Pharmacokinetics, Phases of clinical research, Pivotal trial, Preclinical development, Randomized controlled trial, ... Expand index (12 more) »

Amazon (company)

Amazon.com, Inc., doing business as Amazon, is an American multinational technology company, engaged in e-commerce, cloud computing, online advertising, digital streaming, and artificial intelligence.

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Antiviral drug

Antiviral drugs are a class of medication used for treating viral infections.

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Breakthrough therapy

Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act.

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Capital expenditure

Capital expenditure or capital expense (abbreviated capex, CAPEX, or CapEx) is the money an organization or corporate entity spends to buy, maintain, or improve its fixed assets, such as buildings, vehicles, equipment, or land.

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Capsule (pharmacy)

In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories.

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Cardiology

Cardiology is the study of the heart.

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Cash flow

Cash flow, in general, refers to payments made into or out of a business, project, or financial product.

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Churn rate

Churn rate (sometimes called attrition rate) is a measure of the proportion of individuals or items moving out of a group over a specific period.

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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. Drug development and Clinical trial are drug discovery.

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Comparables

Comparables (or comps) is a real estate appraisal term referring to properties with characteristics that are similar to a subject property whose value is being sought.

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COVID Moonshot

The COVID Moonshot is a collaborative open-science project started in March 2020 with the goal of developing an un-patented oral antiviral drug to treat SARS-CoV-2, the virus causing COVID-19.

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Decision tree

A decision tree is a decision support hierarchical model that uses a tree-like model of decisions and their possible consequences, including chance event outcomes, resource costs, and utility.

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Drug design

Drug 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. Drug development and drug design are drug discovery.

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Drug discovery

In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Drug development and drug discovery are life sciences industry.

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Drug repositioning

Drug repositioning (also called drug repurposing) involves the investigation of existing drugs for new therapeutic purposes. Drug development and drug repositioning are drug discovery.

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Europe, the Middle East and Africa

Europe, the Middle East and Africa, commonly known by its acronym EMEA among the North American business spheres, is a geographical region used by institutions, governments and global spheres of marketing, media and business when referring to this region.

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Food and Drug Administration

The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.

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Forbes

Forbes is an American business magazine founded by B. C. Forbes in 1917 and owned by Hong Kong-based investment group Integrated Whale Media Investments since 2014.

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Formulation

Formulation is a term used in various senses in various applications, both the material and the abstract or formal.

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Generic drug

A generic drug (or simply generic) is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Drug development and generic drug are life sciences industry.

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Google

Google LLC is an American multinational corporation and technology company focusing on online advertising, search engine technology, cloud computing, computer software, quantum computing, e-commerce, consumer electronics, and artificial intelligence (AI).

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Hewlett Packard Enterprise

The Hewlett Packard Enterprise Company (HPE) is an American multinational information technology company based in Spring, Texas.

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IBM

International Business Machines Corporation (using the trademark IBM), nicknamed Big Blue, is an American multinational technology company headquartered in Armonk, New York and present in over 175 countries.

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In vitro

In vitro (meaning in glass, or in the glass) studies are performed with microorganisms, cells, or biological molecules outside their normal biological context.

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Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a European initiative to improve the competitive situation of the European Union in the field of pharmaceutical research.

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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. Drug development and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use are life sciences industry.

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Intravenous therapy

Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein.

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Investigational New Drug

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

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List of pharmaceutical companies

This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia.

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The median of a set of numbers is the value separating the higher half from the lower half of a data sample, a population, or a probability distribution.

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Medication

A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease.

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Medicinal chemistry

Medicinal or pharmaceutical chemistry is a scientific discipline at the intersection of chemistry and pharmacy involved with designing and developing pharmaceutical drugs.

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Metabolism (from μεταβολή metabolē, "change") is the set of life-sustaining chemical reactions in organisms.

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Microsoft

Microsoft Corporation is an American multinational corporation and technology company headquartered in Redmond, Washington.

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Ministry of Health, Labour and Welfare

The is a cabinet level ministry of the Japanese government.

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NASA

The National Aeronautics and Space Administration (NASA) is an independent agency of the U.S. federal government responsible for the civil space program, aeronautics research, and space research.

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National Science Foundation

The U.S. National Science Foundation (NSF) is an independent agency of the United States federal government that supports fundamental research and education in all the non-medical fields of science and engineering.

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New chemical entity

A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a novel, small, chemical molecule drug that is undergoing clinical trials or has received a first approval (not a new use) by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. Drug development and new chemical entity are life sciences industry.

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New Drug Application

The 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.

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Open science

Open science is the movement to make scientific research (including publications, data, physical samples, and software) and its dissemination accessible to all levels of society, amateur or professional.

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Oral medicine

An oral medicine or stomatology doctor/dentist (or stomatologist) has received additional specialized training and experience in the diagnosis and management of oral mucosal abnormalities (growths, ulcers, infection, allergies, immune-mediated and autoimmune disorders) including oral cancer, salivary gland disorders, temporomandibular disorders (e.g.: problems with the TMJ) and facial pain (due to musculoskeletal or neurologic conditions), taste and smell disorders; and recognition of the oral manifestations of systemic and infectious diseases.

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Patent

A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention.

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Pharmaceutical engineering

Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.

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Pharmaceutical industry

The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs that function by being administered to (or self-administered by) patients using such medications with the goal of curing and/or preventing disease (as well as possibly alleviating symptoms of illness and/or injury). Drug development and pharmaceutical industry are life sciences industry.

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Pharmaceutical manufacturing

Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry.

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Pharmacokinetics

Pharmacokinetics (from Ancient Greek pharmakon "drug" and kinetikos "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to describing how the body affects a specific substance after administration. Drug development and Pharmacokinetics are life sciences industry.

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Phases of clinical research

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. Drug development and phases of clinical research are life sciences industry.

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Pivotal trial

A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects.

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Preclinical development

In 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. Drug development and preclinical development are drug discovery.

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Randomized controlled trial

A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control.

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Real options valuation

Real options valuation, also often termed real options analysis,Adam Borison (Stanford University).

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Regulation

Regulation is the management of complex systems according to a set of rules and trends.

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Risk-adjusted net present value

In finance, risk-adjusted net present value (rNPV) or expected net existing value (eNPV) is a method to value risky future cash flows.

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SARS-CoV-2

Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19, the respiratory illness responsible for the COVID-19 pandemic.

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Scripps Research

Scripps Research is a nonprofit American medical research facility that focuses on research and education in the biomedical sciences.

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Side effect

In medicine, a side effect is an effect, whether therapeutic or adverse, that is unintended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequences of the use of a drug.

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Tablet (pharmacy)

A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form.

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Ton

Ton is any of several units of measure of mass, volume or force.

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Toxicity

Toxicity is the degree to which a chemical substance or a particular mixture of substances can damage an organism.

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Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research center at Tufts University in Boston, dedicated to researching drug development. Drug development and Tufts Center for the Study of Drug Development are drug discovery.

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United States Department of Energy

The United States Department of Energy (DOE) is an executive department of the U.S. federal government that oversees U.S. national energy policy and energy production, the research and development of nuclear power, the military's nuclear weapons program, nuclear reactor production for the United States Navy, energy-related research, and energy conservation.

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World Community Grid (WCG) is an effort to create the world's largest volunteer computing platform to tackle scientific research that benefits humanity.

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References

[1] https://en.wikipedia.org/wiki/Drug_development

Also known as Biotech valuation, Clinical development, Drug Research, Drug development pipeline, Drug research and development, Lead Optimization.

, Real options valuation, Regulation, Risk-adjusted net present value, SARS-CoV-2, Scripps Research, Side effect, Tablet (pharmacy), Ton, Toxicity, Tufts Center for the Study of Drug Development, United States Department of Energy, World Community Grid.