Ich guidlines - Study guides, Class notes & Summaries
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ICH Guidlines with 100% correct answers
- Exam (elaborations) • 11 pages • 2024
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Adverse Event (AE) correct answersAny 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. (II.A.1) 
 
Adverse Drug Reaction (ADR) correct answersSubset of AE. Aka "side effect". All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Side effect with reasonable possibility of relatedness ...
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SCRN Study Questions and Answers 2023
- Exam (elaborations) • 13 pages • 2023
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SCRN Study Questions and Answers 2023 
A 67yo man with a hx of HTN, DM, HLD, and smoking presents to the ED. CC of persistent dizziness q1week that has become so severe he now has double vision, N/V. His wife tells you she noticed a L facial droop and slurring. Pt reports weakness in L arm and leg. He denies HA or SZ. Head CT was negative for acute bleed. Upon returning to the room he has become increasingly obtunded and difficult to arouse. You notice he now has a nystagmus and slightly dysconj...
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International Council for Harmonisation (ICH) bundled exams 2024 with 100% correct anwers
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International Council for Harmonisation (ICH) exam 2024 with 100% correct anwers
ICH E2A Definitions and Standards for Expedited Reporting exam 2024 with correct answers

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