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Investigational New Drug

См. также в других словарях:

  • 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 ship an experimental drug across state lines (usually to clinical investigators) before a …   Wikipedia

  • investigational new drug — in·ves·ti·ga·tion·al new drug in .ves ti gā shə nəl n a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical… …   Medical dictionary

  • Compassionate Investigational New Drug program — The Compassionate Investigational New Drug program, or Compassionate IND, is a United States Federal Government ran Investigational New Drug program that allows a limited number of patients to use medical marijuana grown at the University of… …   Wikipedia

  • investigational new drug — medication that has received FDA approval for clinical trials in humans (Medicine), IND …   English contemporary dictionary

  • New Drug Application — Regulation of therapeutic goods in the United States Prescription drugs Over the counter d …   Wikipedia

  • New drug application — The 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. The goals of the NDA are to provide enough information to permit FDA …   Wikipedia

  • New Drug Application — Die New Drug Application (NDA) stellt den Antrag auf Arzneimittelzulassung bei der US amerikanischen Behörde für Lebensmittel und Arzneimittelsicherheit (FDA) dar, welchen Arzneimittelhersteller stellen müssen, um eine Marktzulassung zu erhalten …   Deutsch Wikipedia

  • Drug development — Drug research redirects here. For the journal, see Drug Research (journal). 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… …   Wikipedia

  • Drug Price Competition and Patent Term Restoration Act — Acronym Hatch Waxman amendments Citations Codification …   Wikipedia

  • Drug Master File — or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document… …   Wikipedia

  • investigational — adjective Date: 1905 1. of or relating to investigation < investigational activities > 2. relating to or being a drug or medical procedure that is not approved for general use but is under investigation in clinical trials regarding its safety and …   New Collegiate Dictionary

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