Exam (elaborations)
CCRC Exam Prep - GCP E6(R2) Glossary Study Guide
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Pre-Approved clincal experience - all noxious and unintended responses to a medical product related to any dose Marketed Medicinal products- a response to a drug which is noxious and unintended and which occurs at doess normally used. (ICH GCP E6 1.1) - Adverse Drug Reaction (ADR) Any untoward...
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