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FDA Issues Guidance on Bioequivalence Studies

by Steven Perez | Jul 7, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links

This past May, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were...

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