GUIDELINE Final
E8(R1) General Considerations for Clinical Studies
ABSTRACT — EDITORS' SUMMARY
The umbrella ICH guideline on study design, quality by design, and the risk-proportionality framing that E6(R3) implements operationally.
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PDF · CANONICAL LINK https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf ↗ RELATED · SAME AUTHORITY