USP Dissolution Requirements Quiz

Factors such as drug particle size, excessive lubricant use, coating materials, and inadequate tablet or capsule disintegrants can cause bioavailability and bioinequivalence problems.

The USP includes dissolution requirements for capsules and tablets, which can help define product differences when bioinequivalence is found.

The FDA defines equivalency as pharmaceutical equivalents or pharmaceutical alternatives with identical amounts of the same active drug ingredient, dosage forms, and meeting the same standards of identity, strength, quality, and purity.

<p>Bioequivalent drug products have similar absorption rates and extents under similar experimental conditions.</p> Signup and view all the answers

<p>The equivalence of drug products between competing manufacturers has been a topic of discussion and scientific investigation.</p> Signup and view all the answers