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Flashcards in FDA Drug Development Process Deck (30)
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0
Q

How many phases are in FDA drug approval process?

A

4

1
Q

What federal agency oversees rx and OTC drugs?

A

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

2
Q

What’s the purpose of phase I trial?

A

Safety profile

Dosing range

PK/PD

Open label

Often 1 center may not be done in the US

3
Q

What type of subjects are included in phase I trial?

A

Healthy volunteers

OR

Pts with illness

4
Q

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

A

20-80 subjects

5
Q

Duration of phase I trial?

A

6-12 months

6
Q

What’s the purpose of phase II trial?

A

Safety and EFFICACY (dose response)

IIa - proof of concept; pilot study etc

IIb - well-controlled target population

7
Q

What type of subjects are included in phase II trial?

A

Intended population

8
Q

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

A

100-300 pts

9
Q

Duration of phase II trial?

A

1-2 yrs

10
Q

What’s the purpose of phase III trial?

A

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

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

11
Q

What type of subjects are included in phase III trial?

A

Subjects with indications the drug is seeking to treat

12
Q

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

A

Hundred to thousands of pts

13
Q

Duration of phase III trial?

A

2-3 yrs

14
Q

What’s the purpose of phase IV trial?

A

New indications

QOL

Surveillance studies

15
Q

What type of subjects are included in phase IV trial?

A

Subjects with indications the drug is seeking

16
Q

What type of subjects are included in phase IV trial?

A

Hundreds to thousands

17
Q

Duration of phase IV trial?

A

1-5 yrs

18
Q

When does manufacturer file New Drug Application (NDA)?

A

After phase III

19
Q

What’s phase IV trial also known as?

A

Post-marketing studies

20
Q

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

A

Labeling changes

New dose

New strength

New manufacturing process

21
Q

What reference is used to determine bioequivalence?

A

Orange boom

22
Q

What does AA rating mean in determining drug bioequivalence?

A

Pdts in conventional dosage forms not presenting bioequivalence problems

23
Q

What does AB rating mean in determining drug bioequivalence?

A

Therapeutically equivalent and can be interchanged

24
Q

What does AN rating mean in determining drug bioequivalence?

A

Solutions and powders for aerosolization

25
Q

What does AO rating mean in determining drug bioequivalence?

A

Injectable oil solutions; these are considered equivalent only when;

Active ingredients
Conc
Type of oil

Are all identical

26
Q

What does AP rating mean in determining drug bioequivalence?

A

Injectable aqueous solutions

27
Q

What does AT rating mean in determining drug bioequivalence?

A

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

28
Q

How are biologics first developed?

A

Using recombinant technology

29
Q

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

A

Storage (refrigerator)

Stability concerns (don’t last as long as oral formulations)

Instructions on admin and adverse effect mgt

Cost - they’re more expensive

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