Quality by Design in Generic Drug Development: Modern Science-Based Approaches
Quality by Design (QbD) has transformed generic drug development by shifting from end-product testing to science-based process control. Learn how FDA-mandated QbD improves approval rates, cuts review times, and enables flexible manufacturing through design spaces and real-time monitoring.
Are Generic Drugs Copies? The Truth Behind the Myth
Generic drugs are not copies-they're scientifically proven equivalents to brand-name medications. They work the same, cost far less, and are held to the same safety standards. Here's the truth behind the myth.
Placebo Effect with Generics: Why Perception Shapes Medication Outcomes
Generic drugs work the same as brand-name versions, but perception often makes people feel they don’t. Learn how expectations, branding, and price shape your body’s response-even when the pill is identical.
Contamination Controls: Preventing Adulteration in Generic Drug Manufacturing
Contamination controls in generic drug manufacturing prevent harmful adulteration through strict cleanroom standards, validated cleaning, real-time monitoring, and human error reduction-ensuring patient safety and regulatory compliance.
Bioequivalence Studies: What the FDA Requires Manufacturers to Prove
The FDA requires generic drug makers to prove bioequivalence through strict pharmacokinetic studies showing their product matches the brand-name drug in absorption and blood levels. Learn how the 80/125 rule, biowaivers, and NTID guidelines ensure safety and effectiveness.