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
Therapeutic Use Study
Examples:
-comparative effectiveness studies
-studies of mortality/morbidity outcomes
-studies of additional endpoints
-large simple trials
-pharmacoeconomic studies
Phase 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, assessment
of pharmacodynamics, and early meausrment of drug activity
Pharmacokinetics Study
-PI
-assess the clearance of the drug and to anticipate possible accumulation of parent drug or
metabolites and potential drug-drug interactions
Assessment of pharmacodynamics Study
-PI
-may be conducted in healthy volunteer subjects or pt's with the target disease
-can provide early estimates of activity and potential efficacy and may guide dosage and does
regiment in later studies
Phase II Study
-most typical kind of study in therapeutic exploratory
-start with the initiation of studies in which the primary objective is to explore therapeutic
efficacy in pt's
-pt's selected by narrow criteria
-Goal: determine does and regimen for PIII trials
- Doses are usually less than the highest dose used in PI studies
Phase III Study
-most typical kind of study-therapeutic confirmatory study
-confirm preliminary evidence accumulated in PII that a drug is safe and effective for use in
intended indication and recipient population
-provide an adequate basis for marketing approval
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
Therapeutic Use Study
Examples:
-comparative effectiveness studies
-studies of mortality/morbidity outcomes
-studies of additional endpoints
-large simple trials
-pharmacoeconomic studies
Phase 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, assessment
of pharmacodynamics, and early meausrment of drug activity
Pharmacokinetics Study
-PI
-assess the clearance of the drug and to anticipate possible accumulation of parent drug or
metabolites and potential drug-drug interactions
Assessment of pharmacodynamics Study
-PI
-may be conducted in healthy volunteer subjects or pt's with the target disease
-can provide early estimates of activity and potential efficacy and may guide dosage and does
regiment in later studies
Phase II Study
-most typical kind of study in therapeutic exploratory
-start with the initiation of studies in which the primary objective is to explore therapeutic
efficacy in pt's
-pt's selected by narrow criteria
-Goal: determine does and regimen for PIII trials
- Doses are usually less than the highest dose used in PI studies
Phase III Study
-most typical kind of study-therapeutic confirmatory study
-confirm preliminary evidence accumulated in PII that a drug is safe and effective for use in
intended indication and recipient population
-provide an adequate basis for marketing approval
