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

42256

Card Set

Econ Exam 2

Description

drug development, consumer behavior, drug utilization trends

Updated

2010-10-15T00:06:57Z

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