E11(R1) Step 5 Clinical investigation of medicinal ...
enhancing clinical research, reducing unnecessary clinical trials, and informing clinical decisions in pediatric practice. 3. Commonality of scientific approach for pediatric drug development programs General principles outlined in ICH E11 (2000) Sections 1.4 and 2.1 continue to apply. Pediatric drug
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Guideline for good clinical practice E6(R2)
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