ACRP Key Terms for CCRC exam, CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 3.4.21
3 views 0 purchase
Course
CCRC
Institution
University Of Illinois - Chicago
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 pharmac...
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Classroom. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $11.49. You're not tied to anything after your purchase.