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E6 Good Clinical Practice

In the FDA s Guidance for Industry E6 Good Clinical Practice Consolidated Guidance, an adverse event is defined as follows ... [Pg.32]

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidance for Industry E6 - Good Clinical Practice Consolidated Guidance, Geneva, Switzerland, April 1996, Available at www.fda.gov/cder/guidance/ 959fnl.pdf... [Pg.443]

Normas de Buenas Practica Clinicas (BPC) English version E6 Good Clinical Practice Consolidated Guideline. (Issued April 1996)... [Pg.348]

E = Efficacy topics, that is, those relating to clinical studies in human subject. Examples E4 Dose-Response Studies, Carcinogenicity Testing, E6 Good Clinical Practices. [Pg.2914]

El clinical safety for drugs used in long-term treatment E3 clinical study reports E4 dose—response studies E5 ethnic factors E6 good clinical practice E7 clinical trials in geriatric population... [Pg.115]

See other pages where E6 Good Clinical Practice is mentioned: [Pg.7]    [Pg.303]    [Pg.304]    [Pg.306]    [Pg.306]    [Pg.306]    [Pg.309]    [Pg.311]    [Pg.312]    [Pg.313]    [Pg.314]    [Pg.315]    [Pg.316]    [Pg.70]    [Pg.762]    [Pg.3074]    [Pg.148]    [Pg.210]    [Pg.234]    [Pg.76]   
See also in sourсe #XX -- [ Pg.7 , Pg.295 ]



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