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          Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry
					
		
		January 2020


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2017-D-5961
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This final guidance helps sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and determine essential information to communicate in labeling.

This final guidance describes clinical studies to evaluate the DDI potential of an investigational drug, including: (1) the timing and design of the clinical studies; (2) the interpretation of the study results; and (3) the options for managing DDIs in patients. Specifically, this guidance provides considerations for evaluating pharmacokinetic cytochrome P450 (CYP) enzyme- or transporter-mediated interactions.


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-5961.

                                                                                  Content current as of:
      05/07/2020
         
                  
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