Tag: generic drugs

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.

Stability and Shelf Life: How Generic Products Degrade and Why Safety Depends on Science Dec 8, 2025

Stability and Shelf Life: How Generic Products Degrade and Why Safety Depends on Science

Generic drugs may look identical to brand-name versions, but their stability and shelf life can differ due to formulation and packaging choices. Learn how degradation affects safety, why accelerated testing can miss critical failures, and what regulators and manufacturers are doing to improve reliability.