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          Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry
					
		
		August 2018


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2018-D-2614
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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. The guidance is intended to describe when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-2614.

                                                                                  Content current as of:
      08/09/2018
         
                  
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