How to design a bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs)

How to design a bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).
We have already discussed about what is an abbreviated new drug applications (ANDA) on this website.

In order to sell a pharmaceutical product in United States it is required for any pharmaceutical company to get an approval for their drug and the application is required to submit an ANDA which contains all data about safety and efficacy, pharmacological and pharmacokinetic data about the drug product applied, which are required by applying pharmaceutical company to establish and demonstrate in their laboratories with all supportive documents.

What Are (Bioequivalence) BE Studies?

To obtain an approval for an ANDA, the applying pharmaceutical company, or the applicant is required to demonstrate, along with other requirements, that the product which they have applied for approval to US FDA contains same active ingredient, has the same dosage form and strength, and the route of administration and conditions of use as the listed drug , and that the projected , or applied drug product is bioequivalent to the reference listed drug (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)).

If the applied drug shows its desired activities on body after its absorption into the bloodstream, then the bioequivalent drug products are those products which do not demonstrate any significant difference in the rate and extent of absorption of the therapeutic ingredient (21 U.S.C. 355(j)(8)(B); 21 CFR 320.1(e)).

If a drug which is not required to be absorbed into the bloodstream, FDA may assigne an alternative methods to show bioequivalence that can detect a significant difference between the drug and the listed drug in safety and therapeutic effect (21 U.S.C. 355(j)(8)(C); 21 CFR 320.24).

BE (Bioequivalence )studies are carried out to support of ANDA submissions with the intention of demonstrating bioequivalence between a proposed generic drug product and its reference listed drug.

The regulations governing BE are provided at 21 CFR part 320.

If the US FDA determines that, as required by the statute and regulations (21 U.S.C. 355(j)(2); 21 CFR 314.94), an ANDA contains adequate evidence that the proposed generic drug product is bioequivalent to its reference listed drug and the application meets the other requirements for approval, FDA will approve the ANDA. In assessing whether an ANDA contains adequate evidence of BE, the US FDA considers available relevant information, which may include information submitted by the public to dockets for citizen petitions and product specific BE recommendations.

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