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Sample size determination in bioequivalence studies using statistical assurance
AIMS: Bioequivalence (BE) trials aim to demonstrate that the 90% confidence interval of the T/R‐ratio of the pharmacokinetic metrics between two formulations (test [T] and reference [R]) of a drug is fully included in the acceptance interval [0.80, 1.25]. Traditionally, the sample size of BE trials...
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| Publicado no: | Br J Clin Pharmacol |
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| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6783617/ https://ncbi.nlm.nih.gov/pubmed/31276603 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.14055 |
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