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ACRP CCRA Exam Prep 100% SOLUTION

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ACRP CCRA Exam Prep 100% SOLUTION Phase I Trial AKA - ANSWER Human Pharmacology Phase I Trial - ANSWER -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 - ANSWER Therapeutic Exploratory Phase II Trial - ANSWER -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therapeutic dose. 50 - 500 subjects with specific diseases. -Several months to two years in duration Phase III Trial AKA - ANSWER Therapeutic Confirmatory Phase III Trial - ANSWER -Demonstrate/confirm efficacy. -Establish safety profile. -provide an adequate basis for assessing risk/benefit. -Establish dose-response relationship. -Can include several hundred to several thousand.Usually lasts a few year

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