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Guidance for industry : submission of summary bioequivalence data for ANDAs.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]
Subjects:
Drugs > United States > Therapeutic equivalency.
Drugs > Certification > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS112216
Description
Item Description:Title from title screen (viewed on May 5, 2009).
"Draft guidance."
"April 2009."
Electronic resource.
Physical Description:i, 9 pages : digital, PDF file.
Format:Mode of access: Internet from the CDER web site. Address as of 5/5/09: http://www.fda.gov/cder/guidance/8363dft.pdf ; current access available via PURL.