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          Dissolution Testing of Immediate Release Solid Oral Dosage FormsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Dissolution Testing of Immediate Release Solid Oral Dosage Forms
					
		
		August 1997


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-1997-D-0187
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms.'' The purpose of this guidance document is to provide general recommendations for dissolution testing, approaches for setting dissolution specifications related to biopharmaceutic characteristics of the drug substance, statistical methods for comparing dissolution profiles, and a process to help determine when dissolution testing is sufficient to grant a waiver for an in vivo bioequivalence study. This guidance document also provides recommendations for dissolution tests to help ensure continuous drug product quality and performance after certain postapproval manufacturing changes.


 
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						All written comments should be identified with this document's docket number: FDA-1997-D-0187.

                                                                                  Content current as of:
      10/17/2019
         
                  
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