Question

How Does DIDFA Define Interchangeability? How Is It Determined That the Drug Is Interchangeable?

Option 1: Therapeutic equivalence, Bioequivalence
Option 2: Dosage form, Chemical structure
Option 3: Manufacturer reputation, Marketing
Option 4: Price, Availability, Brand popularity

Answer 1

The U.S. FDA determines drug interchangeability based on therapeutic equivalence and bioequivalence.

Step-by-step explanation:

The U.S. Food and Drug Administration (FDA) defines interchangeability of drugs based on two main factors: therapeutic equivalence and bioequivalence.

Therapeutic equivalence means that the generic drug has the same active ingredient(s), strength, dosage form, and route of administration as the brand-name drug. It must also have the same clinical effects and safety profile.

Bioequivalence refers to how closely the generic drug matches the brand-name drug in terms of its rate and extent of absorption into the bloodstream. To determine bioequivalence, the FDA conducts studies comparing the generic drug with the brand-name drug to ensure that they are very similar in their pharmacokinetic properties.