Complex generic drugs like liposomal injectables and inhalers are far harder to approve than simple pills due to scientific, regulatory, and manufacturing hurdles. The FDA is working to improve approval rates, but progress remains slow.
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Bioavailability studies ensure generic drugs work like brand-name versions by measuring how much and how fast the active ingredient enters the bloodstream. The FDA uses AUC and Cmax data to confirm equivalence within an 80-125% range.
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