GUIDELINE FOR GOOD CLINICAL PRACTICE - ICH Official web …
Guideline for Good Clinical Practice 1. GLOSSARY 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered ................
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