Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus
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DOI: 10.2147/dhps.s256455
Abstract: Abstract Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone… read more here.
Keywords: generic daily; therapeutic index; narrow therapeutic; tacrolimus ... See more keywords
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
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DOI: 10.3390/pharmaceutics14112349
Abstract: Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the European Union is currently established by demonstrating that the 90% confidence interval for the ratio of the population geometric means of the test… read more here.
Keywords: therapeutic index; acceptance range; range; drugs european ... See more keywords