ACRP Key Terms for CCRC exam, CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 3.4.21

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ACRP Key Terms for CCRC exam, CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 3.4.21. Human Pharmacology Study -Assess Tolerance -Define/Describe pharmacokinetics ... and pharmacodynamics -explore drug metabolism and drug interactions -estimate activity Human Pharmacology Study Examples: -dose tolerance studies -single and multiple does pharmacokinetics and pharmacodynamic studies -drug interaction studies Therapeutic Exploratory Study -explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design, endpoints, methodologies Therapeutic Exploratory Study Examples: -earliest trials of relatively short duration in well-defined narrow pt. populations, using surrogate or phamalogical endpoints -does-response exploration studies Therapeutic Confirmatory Study -demonstrate/confirm efficacy (the ability to produce a desired or intended result). -establish safety profile -provide an adequate basis for assessing the benefit/risk relationship to support licensing -establish dose-response relationship Therapeutic Confirmatory Study Examples: -adequate and well controlled studies to establish efficacy -randomized parallel dose-response studies -clinical safety studies - studies of mortality/morbidity outcomes -large simple trials -comparative studies Therapeutic Use Study -refine understanding of benefit/risk relationship in general or special populations/environments -identify less common adverse reactions -refine dosing recommedation [Show More]

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