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Postmarketing approval, clinical trials phase

Phase rv clinical trials are postmarketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation. This is... [Pg.183]

Demonstration of safety Premarket approval required Testing in animals Phase I/II/III clinical trials Post marketing surveillance system Manufacturer must meet OTC monograph standards 1 Premarketing approval or postmarketing surveillance not required Citation of existing literature... [Pg.470]

See other pages where Postmarketing approval, clinical trials phase is mentioned: [Pg.95]    [Pg.83]    [Pg.148]    [Pg.321]    [Pg.325]    [Pg.139]    [Pg.1088]    [Pg.2802]    [Pg.176]    [Pg.128]    [Pg.136]    [Pg.136]    [Pg.26]    [Pg.7]    [Pg.74]    [Pg.280]    [Pg.5]    [Pg.5]    [Pg.837]    [Pg.128]    [Pg.15]    [Pg.82]   
See also in sourсe #XX -- [ Pg.183 ]



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Clinical phase

Clinical trials approval

Clinical trials phases

Phase 1 trials

Postmarketing approval, clinical trials

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