ICH GC - Study guides, Class notes & Summaries

Adverse Drug Reaction (ADR) - ANSWER All noxious and unintended responses to a medicinal product related to any dose E6(R1) 1 - ANSWER Glossary of terms Adverse Event (AE) - ANSWER Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment--any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medicinal pro...