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BIOEQUIVALENCE STANDARDS

This article was originally published in The Gold Sheet

Executive Summary

...for nasal solutions draw FDA and industry attention to the issue of how large a regulatory role in vitro methods can play for novel dosage forms. An industry group is asserting that the in vitro methods for the nasal solutions are not uniform enough yet to replace the need for clinical BE testing. At the same time, manufacturers continue to urge more FDA flexibility in quality control testing requirements for inhalation/ nasal dosage forms. With the role of dissolution testing as a bioequivalence barometer continuing to expand for oral solid dosage forms, industry is seeking refinements that will make the methodology more efficient and effective. FDA investigators, meanwhile, are citing firms when dissolution testing practices do not match GMP standards.

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