Acrp Key Terms For Ccrc Exam, Ccrc Exam,acrp Ccrc Exam Prep, Ccrc Exam Prep,acrp Ccrc, *ccrc Study Set 3.4.21

ACRP Key Terms for CCRC exam, CCRC Exam,ACRP CCRC EXAM PREP, CCRC Exam Prep,ACRP CCRC, *CCRC Study Set 3.4.21Human Pharmacology Study -Assess Tolerance-Define/Describe pharmacokinetics and pharmacodynamics-explore drug metabolism and drug interactions-estimate activityHuman Pharmacology Study Examples:-dose tolerance studies-single and multiple does pharmacokinetics and pharmacodynamic studies-drug interaction studiesTherapeutic Exploratory Study-explore use for the targeted indication-estimate dosage for subsequent studies-provide basis for confirmatory study design, endpoints, methodologiesTherapeutic Exploratory Study Examples:-earliest trials of relatively short duration in well-defined narrow pt. populations, using surrogate or phamalogical endpoints-does-response exploration studiesTherapeutic 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/riskrelationship to support licensing-establish dose-response relationshipTherapeutic 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 studiesTherapeutic Use Study -refine understanding of benefit/risk relationship in general or special populations/environments-identify less common adverse reactions-refine dosing recommedationTherapeutic Use Study Examples:-comparative effectiveness studies-studies of mortality/morbidity outcomes-studies of additional endpoints-large simple trials-pharmacoeconomic studiesPhase I Study -most typical kind study-human pharm.-usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of pts.involve one or more of: estimation of initial safety and tolerability, pharmacokinetics, assessmentof pharmacodynamics,