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a new drug

См. также в других словарях:

  • new drug — n a drug that has not been declared safe and effective by qualified experts under the conditions prescribed, recommended, or suggested in the label and that may be a new chemical formula or an established drug prescribed for use in a new way …   Medical dictionary

  • New drug development — may refer to both: Drug discovery Drug development This disambiguation page lists articles associated with the same title. If an internal link led you here, you may wish to change the link …   Wikipedia

  • 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

  • new drug — noun Date: circa 1951 a drug that has not been declared safe and effective by qualified experts under the conditions prescribed, recommended, or suggested in the label and that may be a new chemical formula or an established drug prescribed for… …   New Collegiate Dictionary

  • new drug — noun : a drug that has not been declared safe and effective by qualified experts under the conditions prescribed, recommended, or suggested in the label and that may be a new chemical formula or an established drug prescribed for use in a new way …   Useful english dictionary

  • 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

  • investigative new drug — inves′tigative new′ drug′ n. pha an unproven drug that is approved by the Food and Drug Administration for restricted use in clinical trials …   From formal English to slang

  • investigative new drug — Pharm. a regulatory classification assigned by the U.S. Food and Drug Administration to an unproven drug, allowing its use in approved studies with human patients. Abbr.: IND * * * …   Universalium

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