Tag: bioequivalence

8 Feb 2026

FDA Safety Standards: How Generic Drugs Meet Brand Name Drug Requirements

The FDA requires generic drugs to meet the same safety and effectiveness standards as brand-name drugs. Learn how bioequivalence testing, manufacturing rules, and strict oversight ensure generics are just as reliable - and why they save billions without compromising health.

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26 Jan 2026

How Pharmacists Verify Generic Equivalence: Practice Standards

Pharmacists verify generic equivalence using the FDA's Orange Book to ensure generics are therapeutically equivalent to brand-name drugs. This process relies on pharmaceutical and bioequivalence data, legal standards, and strict substitution rules to keep patients safe and costs low.

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12 Nov 2025

Pharmacokinetic Studies: The Real Standard for Proving Generic Drug Equivalence

Pharmacokinetic studies are the primary method used to prove generic drugs work like brand-name versions, but they’re not foolproof. Learn how they work, where they fall short, and what’s changing in drug approval.

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