FDA mulls changes to bioequivalence standards

Traynor, Kate
June 2010
American Journal of Health-System Pharmacy;6/1/2010, Vol. 67 Issue 11, p864
Academic Journal
The article reports that the U.S. Food and Drug Administration (FDA) will impose stricter bioequivalence standards on narrow therapeutic index (NTI). It mentions that this decision was taken by the members of FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology at a meeting held at Silver Spring, Maryland, on April 13, 2010. According to FDA even a small mistake in the dosage of NTI drugs could lead to serious therapeutic failures and drug reactions.


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