DRUG EVALUATION, FDA PHASE I
\dɹˈʌɡ ɪvˌaljuːˈe͡ɪʃən], \dɹˈʌɡ ɪvˌaljuːˈeɪʃən], \d_ɹ_ˈʌ_ɡ ɪ_v_ˌa_l_j_uː_ˈeɪ_ʃ_ə_n]\
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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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Word of the day
Procollagen Proline Dioxygenase
- mixed-function oxygenase that catalyzes hydroxylation prolyl-glycyl-containing-peptide, usually in protocollagen, hydroxyprolylglycyl-peptide. The enzyme utilizes molecular oxygen with a concomitant oxidative decarboxylation of 2-oxoglutarate to succinate. EC 1.14.11.2.