The U.S. Food and Drug Administration (FDA) has revised its recommendations for how generic-drug makers can prove that their products are released into the human body in the same manner as brand-name counterparts, issuing high-level guidance covering an array of approaches. In its draft guidance announced in November, the FDA spelled out general study characteristics to determine so-called bioequivalence. That refers to how fast and how much of an active ingredient shows up at the area of a person’s body where it’s intended to work. Separate guidance will be coming soon to describe studies of bioequivalence for new brand-name drugs, with regulators saying it was time to split the matters up. The guidance said “FDA has determined that separating guidances according to application type will be beneficial to applicants.”
In one respect, the guidance is fairly general, as it doesn’t cover specific products. The FDA has produced individual guidances covering appropriate study structures for 1,100 distinct medicines. But there is also substantial detail on the most common study parameters and different ways to analyze certain categories of drugs — information that can supplement the product-specific guidances. For example, a description of typical study design talks about when patients can drink water and eat food, whether multiple doses can be supplied and how much time should separate doses of generic and brand-name products to ensure there’s no overlap.
The guidance also addresses different dosage forms, such as elixirs, chewable tablets and extended-release capsules. It also talks about how to determine whether alcoholic beverages will alter the manner in which a drug is released and its functions. One section of the document deals with “complex drug substances,” for which bioequivalence is more difficult to ascertain. The FDA noted:
Some or all of the components of these complex drug substances cannot be fully characterized with regard to chemical structure and/or biological activity. Rather, we recommend that applicants base [bioequivalence] studies on a small number of markers of rate and extent of absorption.
For most products, drugmakers will be expected to use so-called pharmacokinetic studies that look at the speed and extent of drug absorption in a patient, but in certain circumstances, it may be acceptable to perform in vitro testing or extrapolate results based on therapeutics results of a clinical trial, according to the FDA.
Sources: Jeff Overley and Law360.com
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