FDA Drug Approval And Therapeutic Equivalence

Question 0

Phase 2 study

Answer 0

Looks at the safety and efficacy of the drug in the intended population

Usually 100 to 300 patients for 1 to 2 years

After this the FDA has to approve phase III trials before enrollment can begin

Question 1

Phase 1 study

Answer 1

Focuses on the safety and pharmacology of the compound

Low doses are given to help patients

Usually 20 to 80 subjects for 6 to 12 months

Will be done in patients with illness in the cases of severe life-threatening diagnosis

Question 2

Phase 3 trial

Answer 2

Again looks at safety and efficacy at the dose and schedule you are seeking approval for in subjects with indications for the drug

Typically hundreds to thousands of patients for 2 to 3 years

This is designed to confirm the results of the phase 2 trial

Question 3

What to do after phase 3 trial

Answer 3

The manufacturer files a new drug application

The FDA has one year to review the NDA

The FDA accept, reject or require further study

Further study is usually in the form of phase 4 trials or post marketing surveillance

Question 4

Phase 4 study

Answer 4

Shows the drug and the general population

Shows long-term effects of the drug

Used for new indications quality-of-life examination and surveillance studies

Usually hundreds to thousands of patients from 1 to 5 years

Question 5

Supplemental new drug application

Answer 5

Required for labeling changes, new dose, new strength, and new manufacturing processes

Question 6

Where do you look for bioequivalence

Answer 6

Orange book

Question 7

AA

Answer 7

Products in conventional dosage forms not presenting bioequivalence problems

Question 8

AB

Answer 8

Drugs that have been proven to meet the necessary bioequivalence requirements

Drugs coded as AB are therapeutically equivalent and can be interchanged (brand to generic)

Note if it is AB1 AB2 or AB3 drugs in AB1 are only interchangeable with drugs in AB1 and so forth

Question 9

AN

Answer 9

Solutions and powders for aerosolization

Question 10

AO

Answer 10

Injectable oil solutions and are considered to be pharmaceutically and therapeutically equivalent only when the active ingredient, it’s concentration, and the type of oil used as a vehicle are all identical

Question 11

AP

Answer 11

Pertains to Injectable aqueous solutions

Question 12

AT

Answer 12

Topical products including ophthalmic, otic, rectal, and vaginal administrations formulated as solutions, creams, appointments, gels, lotions, paste, sprays and suppositories

Question 13

Difference between pharmaceutically equivalent and therapeutically equivalent

Answer 13

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