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Futility Rules in Bioequivalence Trials with Sequential Designs
Health Canada, the US Food and Drug Administration, as well as the European Medicines Agency consider sequential designs acceptable for bioequivalence studies as long as the type I error is controlled at 5%. The EU guideline explicitly asks for specification of stopping rules, so the goal of this wo...
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| Main Author: | |
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| Format: | Artigo |
| Language: | Inglês |
| Published: |
Springer US
2013
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| Subjects: | |
| Online Access: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3889523/ https://ncbi.nlm.nih.gov/pubmed/24218038 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9540-0 |
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