Guidance for Industry

BIOEQUIVALENCE GUIDANCE

(This version of the guidance replaces the version titled “Bioequivalence Guidance” that was made available on October 9, 2002. This document has been revised to update the contact information and typographical errors in the equation) Section III.A. of this guidance has been superceded by CDER's guidance entitled "Bioanalytical Method Validation". Any general questions regarding the application of the Bioanalytical Method Validation guidance to new animal drugs should be directed to Marilyn Martinez, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, (240)276-8357, marilyn.martinez@fda.hhs.gov. Any questions regarding analytical methods for tissue residues should be directed to Valerie Reeves, 7500 Standish Pl., Rockville, MD 20855, (240)276-8207, valerie.reeves@fda.hhs.gov .

 

This document is intended to provide guidance for the design and analysis of in vivo bioequivalence studies. This revision to the version that was made available in April 1996 adds an illustrative example of how to calculate confidence bounds when log transformed data are used.

 

Comments and suggestions regarding this guidance document should be submitted to the Divison of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number (94D0401). Additional information on the 1996 guidance document can be found in the Federal Register (Vol. 61, No. 102, May 24, 1996).

 

Comments will be accepted at any time. For questions regarding this guidance document, contact Ken J. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.

 

U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM) November 8, 2006