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