PHASE 1 CLINICAL TRIALS
\fˈe͡ɪz wˈɒn klˈɪnɪkə͡l tɹˈa͡ɪə͡lz], \fˈeɪz wˈɒn klˈɪnɪkəl tɹˈaɪəlz], \f_ˈeɪ_z w_ˈɒ_n k_l_ˈɪ_n_ɪ_k_əl t_ɹ_ˈaɪ_əl_z]\
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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.
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