ICH E19 Optimisation of Safety Data Collection

Titel:
ICH E19 Optimisation of Safety Data Collection
Herkunft/Verlag:

ICH

Inhalt:
This new Guideline is proposed to provide Harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.

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