FDA releases the Final Guidance on Dissolution Testing and Acceptance Criteria for ImmediateRelease Solid Oral Dosage Form DP Containing High Solubility DS

FDA Final Guidance Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances was released on August 9, 2018. This guidance was developed to provide manufacturers with recommendations on the data expected in relation to dissolution testing in new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), for orally administered immediate release (IR) drug products containing highly soluble drug substances and meeting the conditions described in section III of this guidance.

The guidance document can be found here.