翻訳と辞書 Words near each other ・ Investigation and arrest of Alfred Dreyfus ・ Investigation Bureau for Railway, Funicular and Boat Accidents ・ Investigation Committee on the Accident at the Fukushima Nuclear Power Stations of Tokyo Electric Power Company ・ Investigation Discovery ・ Investigation Discovery (Canada) ・ Investigation Discovery (Latin America) ・ Investigation Discovery Europe ・ Investigation Division of the Central Board of Direct Taxes ・ Investigation Held by Kolobki ・ Investigation Held by ZnaToKi ・ Investigation into the 2012 Benghazi attack ・ Investigation of a Citizen Above Suspicion ・ Investigation of a Flame ・ Investigation Task Force Sweep ・ Investigational Device Exemption ・ Investigational New Drug ・ Investigations and prosecutions relating to the Mountain Meadows massacre ・ Investigations in Numbers, Data, and Space ・ Investigations into Germanic Mythology ・ Investigations into the Fukushima Daiichi nuclear disaster ・ Investigations of a Dog ・ Investigations Police of Chile ・ Investigations since the 2000 Fijian coup d'état ・ Investigative Committee of Russia ・ Investigative Data Warehouse ・ Investigative Documentaries ・ Investigative journalism ・ Investigative Journalism (Community) ・ Investigative judgment ・ Investigative Newsource Dictionary Lists mini英和辞書 mini和英辞書 Webster 1913 Latin-English FOLDOC Wikipedia English ウィキペディア

翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Investigational New Drug ： ウィキペディア英語版 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 marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial. Regulations are primarily at . ==Criteria for application== An IND is required for a clinical study if it is intended to support a: * New indication * Change in the approved route of administration or dosage level * Change in the approved patient population (e.g. pediatric) or a population at greater or increase of risk (elderly, HIV positive, immunocompromised) * Significant change in the promotion of an approved drug 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Investigational New Drug」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.