FDA Drug Development Process Flashcards
How many phases are in FDA drug approval process?
4
What federal agency oversees rx and OTC drugs?
Food and Drug Admin (FDA) Center for Drug Evaluation and Research (CDER)
What’s the purpose of phase I trial?
Safety profile
Dosing range
PK/PD
Open label
Often 1 center may not be done in the US
What type of subjects are included in phase I trial?
Healthy volunteers
OR
Pts with illness
(Scope) Number of subjects included in phase I trial?
20-80 subjects
Duration of phase I trial?
6-12 months
What’s the purpose of phase II trial?
Safety and EFFICACY (dose response)
IIa - proof of concept; pilot study etc
IIb - well-controlled target population
What type of subjects are included in phase II trial?
Intended population
(Scope) Number of subjects included in phase II trial?
100-300 pts
Duration of phase II trial?
1-2 yrs
What’s the purpose of phase III trial?
Safety and efficacy AT THE DOSE AND SCHEDULE you’re seeking approval (package labeling)
IIIb - post-NDA - submission trial looking at additional indications
What type of subjects are included in phase III trial?
Subjects with indications the drug is seeking to treat
(Scope) Number of subjects included in phase III trial?
Hundred to thousands of pts
Duration of phase III trial?
2-3 yrs
What’s the purpose of phase IV trial?
New indications
QOL
Surveillance studies
What type of subjects are included in phase IV trial?
Subjects with indications the drug is seeking
What type of subjects are included in phase IV trial?
Hundreds to thousands
Duration of phase IV trial?
1-5 yrs
When does manufacturer file New Drug Application (NDA)?
After phase III
What’s phase IV trial also known as?
Post-marketing studies
When does a manufacturer submit Supplemental New Drug Approval (sNDA)?
Labeling changes
New dose
New strength
New manufacturing process
What reference is used to determine bioequivalence?
Orange boom
What does AA rating mean in determining drug bioequivalence?
Pdts in conventional dosage forms not presenting bioequivalence problems
What does AB rating mean in determining drug bioequivalence?
Therapeutically equivalent and can be interchanged
What does AN rating mean in determining drug bioequivalence?
Solutions and powders for aerosolization
What does AO rating mean in determining drug bioequivalence?
Injectable oil solutions; these are considered equivalent only when;
Active ingredients
Conc
Type of oil
Are all identical
What does AP rating mean in determining drug bioequivalence?
Injectable aqueous solutions
What does AT rating mean in determining drug bioequivalence?
Topical pdts, including those for dermatological, ophthalmic, otic, rectal and vaginal admin, formulated as solutions, creams, ointments, gels, lotion, paste, sprays and suppositories
How are biologics first developed?
Using recombinant technology
What’s the concern for a pharmacist when handling biologics?
Storage (refrigerator)
Stability concerns (don’t last as long as oral formulations)
Instructions on admin and adverse effect mgt
Cost - they’re more expensive
