Shared Flashcard Set

Details

Drug development
FDA rules/scheduling etc
13
Medical
Professional
04/14/2013

Additional Medical Flashcards

 


 

Cards

Term
Drug scheduling (general)
Definition
1: super addicting plus no use (heroine/marijuana)
5: Some potentinal for addiction but mainly small amounts of narcotics in otc preparations (robitussum)
Term
How does the FDA regulate advertising
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
Term
IND
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
Term
NDA
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
Term
Exploratory IND
Definition
"Phase 0 clinical trial"
done by limiting dose and duration of exposure to rapidly get physiologic data
(micro-dosing = 1% of equivalent dose)
Term
Off-label drug uses
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
Term
clinical trials
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
Term
clinical endpoint vs
biomarker vs
surrogate endpoint
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
Term
REMS strategies
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)
Term
ANDA
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
Term
generic biosimilars
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
Term
Orphan drug act
Definition
grants, tax credits, exclusive marketing and patent length for rare diseases or not profitable within 7 yrs
(mostly oncology)
Term
Fast track, priority review, accelerated approval or priority drugs
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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