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Econ Exam 2
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Application for patent
before clinical testing
stages of drug development
preclinical research
preclinical testing
clinical testing
approval
Patent approved
between phase 1 and 2
preclinical time frame
3.5 years
clinical testing time frame
6 years
approval time frame
1 to 2.5 years
total drug approval time
10-13 years
purpose for Phase 1 clinical trials
safe dose range
admin route
absorption and dist. mech
toxicity
purpose for phase II clinical trials
drug safety and efficacy in treating the target disease
purpose for phase III clinical trials
asses efficacy and dose range in treating specific disease in expanded group
sample size for phase I CT
20-80
sample size for phase II CT
12-300
sample size for phase III ct
300-3000
time for phase I CT
< 1 year
time for phase II CT
up to 2 years
Investigational new drug application
between pre-clinical and clinical trials
demonstrates safety for testing on humans
New Drug Application
between clinical and marketing
FDA reveiw
Detailing
information provided by sales force members
Advantages of drug marketing
educates comsumers
increased compliance
increased communication
disadvantages of marketing
increased price
induced demand
drugs move from mfg to consumer via
pharmaceutical industry
wholesalers/distributors
pharmacies
wholesalers
centralize purchasing and sales of drugs from the mfg
erriciency advantages
customized limited distributions for orphan medications
pharmaceutical companies
distribution to ensure additional services take place durgin dispensing of medication
lab monitoring
needle disposal
counseling
special storage req.
Primary arguments presented reguarding drug reimportation
safety issues
harm to recovery of R&D costs
prescription drug costs
perceived susceptibility
pt belief re. chance of getting a condition
perceived severity
pt. belief of how serious a condition is
perceived benefits
belief in efficacy
perceived barriers
tangible and psychological costs of advised action
cues to action
strategies to activate "rediness"
self efficacy
confidence in ability to take action
driving factors behind increased drug use
new products
decreased copayments
post marketing research on clinical guidlines
generic drug use
Author
Rx2013
ID
42256
Card Set
Econ Exam 2
Description
drug development, consumer behavior, drug utilization trends
Updated
2010-10-15T00:06:57Z
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