Today FDA published a guidance for industry entitled Dissolution Testing and Acceptance Criteria for
Immediate-Release Solid Oral Dosage Form Drug Products Containing High
Solubility Drug Substances.   This guidance has been developed to
provide manufacturers with recommendations for submission of new drug
applications (NDAs), investigational new drug applications (INDs), or
abbreviated new drug applications (ANDAs), as appropriate, for orally
administered immediate-release (IR) drug products that contain highly soluble
drug substances. 

NDAs and ANDAs submitted to FDA contain bioavailability (BA) or
bioequivalence (BE) data and in vitro dissolution data that, together with
chemistry, manufacturing, and controls (CMC) data, characterize the quality and
performance of the drug product.  This guidance establishes standard
dissolution methodology and acceptance criteria that are appropriate for highly
soluble drug substances formulated as an IR dosage form that meet the conditions
described in section III of the guidance.  The availability of these
standards will facilitate the rapid development of dissolution methodology and
related acceptance criteria.  In addition, these standards will facilitate
FDA's evaluation of the data submitted in the application.

This guidance finalizes the guidance for industry issued in August
2015 entitled "Dissolution Testing and Specification Criteria for
Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics
Classification System Class 1 and 3 Drugs".  This guidance also clarifies
the recommendations in the guidance for industry on Dissolution Testing of Immediate Release Solid Oral
Dosage Forms for certain high solubility drug substances in IR drug
products.