FDA Drug Approval And Therapeutic Equivalence Flashcards Preview

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Flashcards in FDA Drug Approval And Therapeutic Equivalence Deck (14)

Phase 1 study

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


Phase 2 study

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


Phase 3 trial

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


What to do after phase 3 trial

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


Phase 4 study

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


Supplemental new drug application

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


Where do you look for bioequivalence

Orange book



Products in conventional dosage forms not presenting bioequivalence problems



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



Solutions and powders for aerosolization



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



Pertains to Injectable aqueous solutions



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


Difference between pharmaceutically equivalent and therapeutically equivalent