Tag: bioequivalence

Pharmacokinetic Studies: The Real Standard for Proving Generic Drug Equivalence Dec 24, 2025

Pharmacokinetic Studies: The Real Standard for Proving Generic Drug Equivalence

Pharmacokinetic studies are the main way regulators prove generic drugs work like brand-name versions. But they're not perfect. For some drugs, blood tests don't tell the whole story-and patient safety depends on knowing when they fall short.

Quality by Design in Generic Drug Development: Modern Science-Based Approaches Dec 23, 2025

Quality by Design in Generic Drug Development: Modern Science-Based Approaches

Quality by Design (QbD) is now mandatory for generic drug development, transforming how manufacturers prove bioequivalence. Learn how science-based approaches like design space, CQAs, and PAT reduce costs, speed approvals, and improve product consistency.

False Advertising in Generics: Legal Risks and Rules You Can't Ignore Dec 19, 2025

False Advertising in Generics: Legal Risks and Rules You Can't Ignore

False advertising in generic drugs misleads patients, violates FDA rules, and triggers lawsuits. Learn the legal risks, recent crackdowns, and compliance rules that could save your business or your health.

Complex Generic Drugs: Why Some Products Are Harder to Approve Nov 14, 2025

Complex Generic Drugs: Why Some Products Are Harder to Approve

Complex generic drugs face unique scientific and regulatory hurdles that make approval far harder than for simple generics. From liposomal injections to inhalers, these drugs require advanced testing, unclear guidelines, and millions in investment-delaying affordable access for patients.