Term
| Drug scheduling (general) |
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Definition
1: super addicting plus no use (heroine/marijuana)
5: Some potentinal for addiction but mainly small amounts of narcotics in otc preparations (robitussum) |
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Term
| How does the FDA regulate advertising |
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Definition
1. Prescription after it appears only
2. non-prescription advertising is by FTC
3. department of justice prosecutes promotion of unapproved drug indications by manufacturers |
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Term
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Definition
Investigational New Drug - initial filing FDA asking for permission to begin human testing
Separate IND required for each dosing form, FDA has 30 days to reply with questions
usually requires pharmocokinetics, pharmacodynamics, mechanism, toxicology, drug description etc |
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Term
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Definition
New Drug application: filed after clincal trials of increasing size (phase 1-3): if approved gives permission to market drug
Phase 3 trials require the most resources
BLA equivalent for biological products |
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Term
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Definition
"Phase 0 clinical trial"
done by limiting dose and duration of exposure to rapidly get physiologic data
(micro-dosing = 1% of equivalent dose) |
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Term
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Definition
Not what originally FDA approved for but what may be used by clinicians:
1. amiodarone: for vtac used for afib
2. erthromycin: for resp used for gi |
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Term
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Definition
Phase 1: 20-200 healthy volunteers for mo
(inital data gathering)
Phase 2: 50-500 selected patients 2yrs
(small scale efficacy/safety)
Phase 3: several hundred-10000's yrs
large scale efficacy and safety |
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Term
clinical endpoint vs
biomarker vs
surrogate endpoint |
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Definition
1. clincal endpoint - ultimate desired effect
2. biomarker - measurable in vivo drug response related to clinical end pt
3. surrogate - biomarker in clinical trial as end point
example: tumor size as a surrogate biomarker for cancer survivial |
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Term
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Definition
Risk evaluation management strategies-
1. medication guides
2. communication plans
3. elements to assure safety of use
example- rosiglitazone (diabetic drug shows increase events post mi) |
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Term
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Definition
Abrieviated New Drug Application: Generic drug
must be withing 80-125% drug lvl body (bio equivalent)
must be chemically identical
NO REPEAT CLINICAL TRIALS |
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Term
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Definition
Few and far between because:
many atoms makes costly to analyze
1. post trans mod in body
2. 3-d structure can be altered
3. likelyhood of protein aggregation |
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Term
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Definition
grants, tax credits, exclusive marketing and patent length for rare diseases or not profitable within 7 yrs
(mostly oncology) |
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Term
| Fast track, priority review, accelerated approval or priority drugs |
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Definition
for life-threatening/severely debilitating diseases or un-met needs
fast track - rolling review data
priority review - shorter NDA time (6 vs 12 mo)
accelerated approval - drug approved based off of surrogate endpoints in phase 2 clinical trial (other definitive comes later) |
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