《英文msh詞典》Drug Evaluation,FDA Phase I
[同義詞] Drug Evaluation,FDA Phase I
[主題詞] Clinical Trials,Phase I
[中文釋義] 藥物評價,食品和藥物管理局Ⅰ期
[英文釋義] Studies performed to evaluate the safety of diagnostic,therapeutic,or prophylactic drugs,devices,or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity,metabolism,absorption,elimination,and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.