in clinical trails whats the duration of PHASE IV ?
Correct Answer: indefinite duration of time
Description: Clinical Trials phase 1 = Safety, ADME, Healthy bioactivity, volunteers or subj. w/ drug-drug interaction indications Length (per phase) 20-80 6-12 mos phase 2 = Sho-term side Subjects with effects & efficacy indications Several hundred 1-2 yrs phase 3= Safety & efficacy Basis for labeling, new formulations New indications, QoL, surveillance Subjects with Hundreds-indications thousands Subjects with indications 2-3 yrs phase 4 = Safety & efficacy Basis for labeling, new formulations New indications, QoL, surveillance Subjects with Hundreds-indications thousands Subjects with indications indefinite time and on going ref : kd tripathi 8th ed
Category:
Pharmacology
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