investigational new drug


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investigational new drug (IND)

a drug not yet approved for marketing by the U.S. Food and Drug Administration (FDA) and available only for use in experiments to determine its safety and effectiveness. The use of an investigational new drug in human subjects requires approval by the FDA of an application that includes reports of animal toxicity tests, descriptions of proposed clinical trials, and a list of the investigators and their qualifications.

in·ves·ti·ga·tion·al new drug

(IND) (in-ves'ti-gā'shŭn-ăl nū drŭg)
A pharmacotherapeutic agent that has not been approved for general use by the U.S. Food and Drug Administration, but is in the course of being tested on humans.

drug

(drug) [Fr. drogue, chemical material]
Any substance that, when taken into a living organism, may modify one or more of its functions.

drug of abuse

Any agent that impairs behavior, health, social interactions, or thought and lends itself to compulsive use. Many of these agents, including ecstasy, lysergic acid (LSD), methamphetamines, the opiates, and phencyclidine, are considered controlled substances in the U.S. Alcohol and tobacco products are not traditionally considered to be drugs of abuse although they are addictive and harm many people.

antimicrobial drug

A drug that either kills microorganisms or prevents their growth.

antisense drug

Antisense compound.

brake drug

A popular term for a hormonal agent that prevents excessive growth in children.

club drug

A colloquial term for a drug used for its euphoric or intoxicating effects at a party, rave, nightclub, or bar. Such drugs include ecstasy, gamma hydroxybutyrate, ketamine, and rohypnol.

code drug

A drug to treat acute, life-threatening emergencies including dysrhythmias, cardiac arrest, pulmonary edema, and shock. Code drugs include atropine, epinephrine, morphine, and vasopressin.
See: basic life support; code (3); code cart

counterfeit drug

1. Any drug that has been adulterated, contaminated, diluted, or falsely labeled.
2. Any drug marketed under false pretenses.

designer drug

An illicitly produced drug of abuse. Designer drugs include methamphetamine, fentanyl and its analogues, and phencyclidine hydrochloride (PCP). They have serious side effects or are addictive; deaths and injury from overdose are common.

disease-modifying antirheumatic drug

Abbreviation: DMARD
A drug that is used to treat rheumatoid arthritis and acts more slowly but more effectively than nonsteroidal anti-inflammatory drugs. Such drugs include hydroxychloroquine, methotrexate, and tumor necrosis factor inhibitors.
Synonym: slow-acting antirheumatic drug

gateway drug

A drug of abuse whose use precedes, and is thought to contribute to, the subsequent use of more dangerous or exotic substances, esp. by young people.

hard drug

In biochemistry, a drug that is not metabolized by the cytochrome P450 system in the liver, or transported by intestinal P-glycopeptide.

investigational drug

Abbreviation: IND
A drug available only for experimental purposes because its safety and effectiveness have not been proven.
Synonym: investigational new drug

investigational new drug

Investigational drug.

legend drug

A medication that cannot be obtained legally without a prescription from a licensed health care provider.

look-alike drug

1. Any of a group of solid dosage forms of drugs that mimic various prescription drugs by size, shape, color, and markings. Some of these may be controlled drugs.
2. A drug that works much like another but varies in a minor or insignificant part of its chemical structure.

neuromuscular blocking drug

A type of drug used during the administration of anesthesia to allow surgical access to body cavities, esp. in particular the abdomen and thorax, by preventing voluntary or reflex muscle movement. These drugs are also used to facilitate compliance in critically ill patients undergoing intensive therapy such as mechanical ventilation.

new drug

A drug for which premarketing approval is required by the Food, Drug and Cosmetic Act (a U.S. law granting authority to the FDA to oversee the safety of food, drugs, and cosmetics).

nonprescription drug

An over-the-counter medication.

nonsteroidal anti-inflammatory drug

Abbreviation: NSAID
A drug that has analgesic, anti-inflammatory, and antipyretic actions. NSAIDs are used to treat acute and chronic pain, e.g., of injuries, arthritis, and dysmenorrhea, to reduce inflammation, and to prevent complications in serious illness such as sepsis.

CAUTION!

All NSAIDS increase the risk of gastrointestinal bleeding and ulceration and, to some extent, the risk of renal failure, abnormalities in liver function, myocardial infarction, and stroke. These side effects occur most often in older patients, e.g., those with multiple risk factors for atherosclerotic vascular disease.

Many patients experience side effects of these medications, including upper gastrointestinal inflammation or bleeding. These side effects occur most often in the elderly, tobacco users, and those who drink alcohol. Other potential complications include acute and chronic renal failure, liver function abnormalities, and aseptic meningitis.

Members of this class of drugs include aspirin, ibuprofen, and naproxen.

Patient care

Patients who are sensitive to NSAID therapy are told to inform caregivers so that they will not be given NSAIDs. Patients are instructed to watch for adverse effects when taking NSAIDs and to report any gastrointestinal pain or bleeding. The patient should be cautioned not to take NSAIDs on an empty stomach but with milk, a meal, or an antacid. Skin should be protected from the sun. Pregnant women should avoid NSAIDs during their last trimester.

orphan drug

A drug effective for a certain illness but not profitable for manufacturers to produce.

performance-enhancing drug

Any drug used to gain an advantage in sports. Such drugs may improve endurance or strength or accelerate healing after injury.

pioneer drug

The brand-name or patented version of a drug, later copied to make generic drugs after the patent expires.

psychotherapeutic drug

A drug to improve the principal symptoms, e.g., anxiety, depression, and psychosis, in the mentally disturbed.

psychotropic drug

A drug that affects psychic function, behavior, or experience. Many drugs can be classed as intentionally psychotropic, but many other drugs also occasionally may produce undesired psychotropic side effects.

radioprotective drug

A drug that protects humans against the damaging or lethal effects of ionizing radiation. For example, Lugol's solution blocks the uptake of inhaled or ingested radioactive iodine by the thyroid.

recreational drug

A drug used for enjoyment rather than for a medical purpose.

scheduled drug

See: Controlled Substance Act

slow-acting antirheumatic drug

Abbreviation: SAARD
Disease-modifying antirheumatic drug.

soft drug

1. A drug that is easily metabolized by the body to inactive, nontoxic metabolites.
2. An illicit drug that has fewer psychoactive, addictive, or other adverse effects than a street drug orhard drug.
3. A drug that dissolves in the mouth and is quickly absorbed.

specialty drug

A drug that has unusually complex requirements for development, manufacturing, storage, transportation, administration and/or monitoring. Most drugs in this category are extraordinarily expensive.

street drug

A drug obtained illegally, usually a drug of abuse.

sulfa drug

Any drug of the sulfonamide group possessing bacteriostatic properties.

ulcerogenic drug

A drug, e.g., a nonsteroidal anti-inflammatory drug, that may cause peptic ulcers.
References in periodicals archive ?
After receiving United States Food and Drug Administration's acceptance of the investigational new drug application submission, the firm plans to commence human clinical Phase I/II trials in early 2015.
Phosphagenics, a Melbourne-based biotechnology company, has completed the first of its additional studies aimed to further characterise the TPM/Oxymorphone patch in support of an investigational new drug application with the US Food and Drug Administration, it was reported yesterday.
Lightlake Therapeutics, a United States-based biopharmaceutical company, has filed an investigational new drug application for its naloxone-based opioid overdose reversal nasal spray, it was reported yesterday.
M2 EQUITYBITES-June 25, 2014-Roche submits Investigational New Drug application to start multicentre, Phase II clinical trial of Erivedge
M2 PHARMA-June 25, 2014-Roche submits Investigational New Drug application to start multicentre, Phase II clinical trial of Erivedge
We are extremely pleased with the FDA's response to our Investigational New Drug application for preclinical and clinical studies related to our novel antiviral compound," said Dr.
Tonix Pharmaceuticals, a specialty pharmaceutical product development and commercialisation company, has received approval from the US Food and Drug Administration for its Investigational New Drug application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, it was reported yesterday.
M2 EQUITYBITES-March 3, 2014-Ignyta files investigational new drug application for RXDX-101 with US Food and Drug Administration
M2 PHARMA-March 3, 2014-Ignyta files investigational new drug application for RXDX-101 with US Food and Drug Administration
AVANIR previously announced positive results in the second of two required Phase III clinical trials of Neurodex(TM), an investigational new drug for the treatment of involuntary emotional expression disorder (IEED).
M2 PHARMA-December 3, 2013-Polaris Group files Investigational New Drug Application for ADI-PEG 20 for the treatment of acute myeloid leukemia
M2 EQUITYBITES-December 3, 2013-Polaris Group files Investigational New Drug Application for ADI-PEG 20 for the treatment of acute myeloid leukemia

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