Pharm 2 FDA Flashcards
Phase 1 trial
Healthy control population
-Determine pharmacokinetics/dynamics
Phase 2 trial
Therapeutic exploration
-Determine dosing
Phase 3 trial
Demonstrate and confirm therapeutic benefit, safety, effictiveness
Phase 4 trial
Adverse reaction surveillance
-Not necessary for approval
IND
Investigation of New Drug
- Used by companies to obtain exemptions from interstate transport ban
- For starting studies
NDA
New Drug Application
- After Phase 1,2,3
- Leads to marketing in US
ANDA
Abbreviated NDA
- Used for generics
- Don’t need study human/animal data
- Need to demonstrate BIOEQUIVALENT
Bioavailability for generics
Need 90% Confidence Interval for +/- 20% bioavailability of brand name
Orphan Drugs
Tx rare diseases (Huntington’s, ALS)
-Expedited grants, marketing exclusivity
FDA fast track
Get new drugs to patient earlier
FDA accelerated approval
Fast Track but based on surrogate endpoint (lab markers)
FDA priority review
For drugs that offer major advances in Tx
FDA drug center
CDEA - Center for Drug Evaluation & Research
Off-label prescribing
40% of all prescriptions
-80% OLP for infants and children
Black Box Warning location
In prescribing information
