Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden
The US Food and Drug Administration (FDA) has recently suggested that the bioequivalence (BE) for products of drugs with narrow therapeutic indices (NTI) be assessed by the approach of reference-scaled average BE (SABE). Subsequently, in December, 2012, the FDA issued draft guidances for the compar...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Canadian Society for Pharmaceutical Sciences
2013-11-01
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| Series: | Journal of Pharmacy & Pharmaceutical Sciences |
| Online Access: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/20900 |