FDA Drug Development Process

Question 1

How many phases are in FDA drug approval process?

Answer 1

4

Question 2

What’s the purpose of phase I trial?

Answer 2

Safety profile

Dosing range

PK/PD

Open label

Often 1 center may not be done in the US

Question 3

What type of subjects are included in phase I trial?

Answer 3

Healthy volunteers

OR

Pts with illness

Question 4

(Scope) Number of subjects included in phase I trial?

Answer 4

20-80 subjects

Question 5

Duration of phase I trial?

Answer 5

6-12 months

Question 6

What’s the purpose of phase II trial?

Answer 6

Safety and EFFICACY (dose response)

IIa - proof of concept; pilot study etc

IIb - well-controlled target population

Question 7

What type of subjects are included in phase II trial?

Answer 7

Intended population

Question 8

(Scope) Number of subjects included in phase II trial?

Answer 8

100-300 pts

Question 9

Duration of phase II trial?

Answer 9

1-2 yrs

Question 10

What’s the purpose of phase III trial?

Answer 10

Safety and efficacy AT THE DOSE AND SCHEDULE you’re seeking approval (package labeling)

IIIb - post-NDA - submission trial looking at additional indications

Question 11

What type of subjects are included in phase III trial?

Answer 11

Subjects with indications the drug is seeking to treat

Question 12

(Scope) Number of subjects included in phase III trial?

Answer 12

Hundred to thousands of pts

Question 13

Duration of phase III trial?

Answer 13

2-3 yrs

Question 14

What’s the purpose of phase IV trial?

Answer 14

New indications

QOL

Surveillance studies

Question 15

What type of subjects are included in phase IV trial?

Answer 15

Subjects with indications the drug is seeking

Question 16

What type of subjects are included in phase IV trial?

Answer 16

Hundreds to thousands

Question 17

Duration of phase IV trial?

Answer 17

1-5 yrs

Question 18

When does manufacturer file New Drug Application (NDA)?

Answer 18

After phase III

Question 19

What’s phase IV trial also known as?

Answer 19

Post-marketing studies

Question 20

When does a manufacturer submit Supplemental New Drug Approval (sNDA)?

Answer 20

Labeling changes

New dose

New strength

New manufacturing process

Question 21

What reference is used to determine bioequivalence?

Answer 21

Orange boom

Question 22

What does AA rating mean in determining drug bioequivalence?

Answer 22

Pdts in conventional dosage forms not presenting bioequivalence problems

Question 23

What does AB rating mean in determining drug bioequivalence?

Answer 23

Therapeutically equivalent and can be interchanged

Question 24

What does AN rating mean in determining drug bioequivalence?

Answer 24

Solutions and powders for aerosolization

Question 25

What does AO rating mean in determining drug bioequivalence?

Answer 25

Injectable oil solutions; these are considered equivalent only when; Active ingredients Conc Type of oil Are all identical

Question 26

What does AP rating mean in determining drug bioequivalence?

Answer 26

Injectable aqueous solutions

Question 27

What does AT rating mean in determining drug bioequivalence?

Answer 27

Topical pdts, including those for dermatological, ophthalmic, otic, rectal and vaginal admin, formulated as solutions, creams, ointments, gels, lotion, paste, sprays and suppositories

Question 28

How are biologics first developed?

Answer 28

Using recombinant technology

Question 29

What's the concern for a pharmacist when handling biologics?

Answer 29

Storage (refrigerator) Stability concerns (don't last as long as oral formulations) Instructions on admin and adverse effect mgt Cost - they're more expensive

Question 30

What federal agency oversees rx and OTC drugs?

Answer 30

Food and Drug Admin (FDA) Center for Drug Evaluation and Research (CDER)