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Posted 22 July 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.
Bioequivalence refers to the "absence of a significant difference" between the bioavailability—specifically the extent and rate of absorption—of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the same dose and under the same conditions. "The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug," FDA explains on its website.
Drugs that are deemed to be bioequivalent are, for regulatory purposes, essentially the same.
But in practical terms, generic drug companies are often most concerned with two things:
In order to facilitate that process, FDA regularly publishes what it calls "bioequivalence recommendations for specific products," which contains more than 1,000 recommendations.
These recommendations most often contain the recommended number of bioequivalence studies that must be conducted in order to obtain approval, as well as the general designs of the study, acceptable parameters of bioequivalency, and any other considerations sponsors must keep in mind.
On 22 July 2014, FDA released 37 new BE standards, including ones for generic versions of Janssen's Invokana, Pfizer's Xalkori, Biogen Idec's Tecfidera, and AstraZeneca's Nexium 24HR.
Those guidances are still in draft form. FDA also said it had revised 12 other BE guidances.
The documents are set to be posted on FDA's website on 23 July 2014, and will be available here.
Federal Register Notice
Tags: BE, Bioequivalence, Bioequivalence Standards
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