Bioequivalence studies modified-release drug product

An NDA can be submitted for a previously unapproved new molecular entity, or for a new salt, new ester, prodrug, or other noncovalent derivative of a previously approved new molecular entity, formulated as a modihed-release drug product. The first modified-release drug product for a previously approved immediate-release drug product should be submitted as an NDA. Subsequent modified-release products that are pharmaceutically equivalent and bioequivalent to the listed drug product should be submitted as ANDAs. BA requirements for the NDA of an extended-release product are listed in 320.25(f). The purpose of an in vivo BA study for which a controlled-release claim is made is to determine if all of the following conditions are met. 

Biobatch The lot of drug product formulated for purposes of pharmacokinetic evaluation in a bioavailabUity/bioequivalency study. For modified release solid oral, this batch should be 10% or greater than the proposed commercial production batch or at least 100,000 units, whichever is greater. 

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