Acrp ccra - Study guides, Class notes & Summaries

Adverse Event (AE)/Adverse Experience - Answer- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) - Answer- All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction - Answer- An adverse reaction, the nature or severity of which is not consistent with the a...

ACRP CCRA Exam Prep Questions and Answers 100% Pass Phase I Trial AKA Human Pharmacology Phase I Trial -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA Therapeutic Exploratory Phase II Trial -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therape...

Adverse Event (AE)/Adverse Experience Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product i...

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