Tag: FDA guidelines

Pharmacokinetic Studies and Generic Drug Equivalence: What You Really Need to Know

Pharmacokinetic Studies and Generic Drug Equivalence: What You Really Need to Know

Pharmacokinetic studies are commonly called the 'gold standard' for proving generic drugs work the same as brand-name versions. But the reality is more complex. This article explains how these studies actually work, their limitations for certain drugs, and why regulators use multiple testing methods to ensure safety and effectiveness.