Question

What are the FDA criteria for therapeutic equivalence? Check all that apply.

a) Clinical indication
b) Safety profile
c) Price difference
d) Dosage form
e) Pill shape
f) Route of administration
g) Drug color

Answer 1

The FDA criteria for therapeutic equivalence of generic drugs include clinical indication, safety profile, dosage form, and route of administration.

Step-by-step explanation:

The FDA criteria for therapeutic equivalence of generic drugs include:

1. Clinical indication: Two drugs are considered therapeutically equivalent if they are approved for the same clinical indication or medical condition. This means they are used to treat the same disease or provide the same therapeutic effect.
2. Safety profile: Generic drugs are required to have the same safety profile as their brand-name counterparts. They must undergo rigorous testing to ensure they are as safe and effective as the original drug.
3. Dosage form: Generic drugs must have the same dosage form as the reference drug. For example, if the reference drug is a tablet, the generic drug must also be a tablet.
4. Route of administration: Generic drugs must be administered via the same route as the reference drug. For example, if the reference drug is taken orally, the generic drug must also be taken orally.